StudyFinder
Search Results Within Category "Heart & Vascular"
17 Study Matches
Global Paradise System US Post Approval Study (US GPS)
Regina Maharajh - Regina.Maharajh3@prismahealth.org
ALL
18 years and over
NCT06297291
Inclusion Criteria:
* Signed and dated study informed consent
* Documented history of hypertension
* Documented history of prior or current antihypertensive medication(s)
* Mean seated office systolic BP at screening ≥ 140 mmHg
* Mean pre-procedure home systolic BP of ≥ 135 mmHg
* Estimated glomerular filtration rate (eGFR) of ≥30 mL/min/m2
RADIANCE CAP patients must provide signed and dated informed consent for inclusion in long-term follow-up. No other criteria are required for inclusion.
Exclusion Criteria:
Patients who meet the following will be excluded from participation:
* Patient lacks appropriate renal anatomy for any treatment with the Paradise Catheter
* Patient under the age of 18 years old at the time of consent
* Patient is pregnant
* Patients with transplanted kidney
* Presence of abnormal kidney (or secreting adrenal) tumors
To confirm eligibility for treatment with the Paradise System, the following contraindications listed in the IFU may be determined at the time of procedure prior to treatment:
* Renal arteries with diameter \< 3mm and \> 8mm
* Renal artery with fibromuscular dysplasia (FMD)
* Stented renal artery
* Renal artery aneurysm
* Renal artery diameter stenosis \>30%
* Iliac/femoral artery stenosis precluding insertion of the Paradise Catheter DEVICE: Paradise Ultrasound Renal Denervation Treatment
Hypertension, Cardiovascular Diseases, Vascular Diseases
Blood Pressure, Uncontrolled Hypertension, Essential Hypertension, Resistant Hypertension, Renal Denervation, Ultrasound Renal Denervation
HF2 Registry - Hemodynamic Frontiers in Heart Failure Registry (HF2 Registry)
Kartik Munshi, MPH - kmunshi@kumc.edu
ALL
18 years to 100 years old
NCT06425848
Inclusion Criteria:
• All patients would have been or will be implanted per indications from FDA approval/CHAMPION trial. These would be patients with NYHA (New York Heart Association) Class III heart failure who had a prior hospitalization.
• Patients who meet the expanded FDA indication (BNP elevation without hospitalization or NYHA class II).
Exclusion Criteria:
• Patients less than 18 years of age.
• Pregnant women at the scheduled time of PA pressure sensor implant.
• Patients unable or unwilling to have continuity of care in the heart failure clinic.
DEVICE: Observational
Heart Failure
Pulmonary Artery (PA) pressure monitor
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) (FASTR)
Annemarie Forrest - aforrest@reprievecardio.com
ALL
18 years and over
NA
NCT05174312
Inclusion Criteria:
• Hospitalized with a diagnosis of heart failure as defined by the presence of at least 1 symptom AND 1 sign.
• ≥10 pounds (4.5 kg) above dry weight either by historical weights or as estimated by health care provider.
• Prior use of loop diuretics within 30 says prior to admission.
• ≥ 18 years of age able to provide informed consent and comply with study procedures.
Exclusion Criteria:
• Inability to place Foley catheter or IV catheter.
• Hemodynamic instability.
• Dyspnea due primarily to non-cardiac causes.
• Acute infection with evidence of systemic involvement.
• Estimated glomerular filtration rate (eGFR) \< 20 ml/min/1.73m2 calculated using the MDRD equation or current use of renal replacement therapy.
• Significant left ventricular outflow obstruction, uncorrected complex congenital heart disease, severe stenotic valvular disease, infiltrative or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial infarction requiring treatment, or any other pathology that, in the opinion of the investigator, would make aggressive diuresis poorly tolerated.
• Inability to follow instructions or comply with follow-up procedures.
• Other concomitant disease or condition that investigator deems unsuitable for the study, including drug or alcohol abuse or psychiatric, behavioral or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
• Severe electrolyte abnormalities.
• Presence of active coronavirus disease 2019 (COVID-19) infection.
• Enrollment in another interventional trial during the index hospitalization.
• Inability to return for follow-up study visits.
• Life expectancy less than 3 months.
• Women who are pregnant or intend to become pregnant.
DEVICE: Reprieve Decongestion Management System, DRUG: Diuretic
Acute Decompensated Heart Failure
Feasibility and Efficacy Study of the CardioPulmonary Monitoring (CPM) System in Patients With Chronic Heart Failure
Rebecca Rebain - Rebecca.Rebain@PrismaHealth.org
ALL
18 years and over
PHASE2
NCT05978518
Inclusion Criteria:
Heart failure patients regardless of ejection fraction (HFpEF or HFrEF) with one or more of the following:
* NYHA Class III-IV
* NYHA Class II HF with one or more of the following:
* Chronic Kidney Disease (eGFR\<60 within the past 6 months)
* HF hospitalization (defined as HF listed as the major reason for hospitalization) within 9 months prior to screening visit and NT-proBNP \> 200 pg/ml for patients not in AF or \> 600 pg/m for patients in AF on screening ECG
* NT-proBNP \> 300 pg/ml for patients not in AF or \> 900 pg/ml for patients in AF on the screening visit ECG.
* Chronic obstructive pulmonary disease (COPD)
Exclusion Criteria:
* Under 18 years of age
* Patients with severe COPD (GOLD stage III or IV)
* Limited mobility preventing application of device
* Cognitive impairments that would limit the application and proper use of the device
* Skin allergies or skin sensitivities to silicone-based adhesives
* Pregnancy
* Skin breakdown on the left chest or breast area
* Not willing to shave chest hair if needed to apply device
* Patients on chronic ionotropic therapy
* Patients with any condition that might limit the survival to less than 1 year as assessed by the investigator
* No cellular coverage (Patient's Home) DEVICE: CPM Device + Monitoring, DRUG: CPM Device
Heart Failure
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL) (DEEPER REVEAL)
Carolyn Mascho - cmascho@reflowmedical.com
ALL
18 years and over
NA
NCT05358353
Pre-Procedure
• Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a witness, including a family member, sign on their behalf.
• Life expectancy greater than 1 year in the investigator's opinion.
• Male or non-pregnant female ≥18 years of age at time of consent.
• Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
• For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 3 days prior to the index procedure or greater than or equal to 7 days following the index procedure. Angiographic
• Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed via the true lumen with a guidewire (no subintimal crossing).
• Iliac, SFA and popliteal inflow lesions can be treated using standard of care during the index procedure or greater than or equal to 3 days prior. Note:
• Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
• Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not fractured or otherwise compromised.
• Distal embolic protection is strongly encouraged in cases where atherectomy is used.
• Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
• Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting dissection, thrombus, or aneurysm by angiography.
• Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint. Note:
• If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
• If the peroneal artery is treated, there must be at least one collateral supplying the foot.
• In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries
• Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment.
• Target vessel reference diameter is measured to be between 2.5 to 4.5 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:
• Intravascular Ultrasound (IVUS) (primary)
• Visual estimate using Angiography (secondary)
• Target lesion length is less than or equal to 210mm in length. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm.
• Successful pre-dilatation of the target lesion defined as resulting in stenosis less than or equal to 50% and/or inner lumen diameter greater than or equal to 2.0 mm in diameter, without resulting flow limiting dissection, thrombus, or aneurysm by angiography prior to the insertion of the Bare Temporary Spur Stent System.
• Only one limb and one contiguous vessel may be enrolled per subject. If required, a second modality may be used for treatment in the non-target infrapopliteal vessel. Note:
• Distal embolic protection is strongly recommended in cases using atherectomy.
• Treatment of the target vessel/lesion may be performed only if treatment of the non-target lesion is successful without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography.
• Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion.
• If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performed less than or equal to 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal inflow must still be imaged using angiography during the index procedure.
• Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the Bare Temporary Spur Stent System must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access. Pre-procedure
• Subject unwilling or unlikely to comply with the 1-year duration of the study in the opinion of the investigator.
• Subject is pregnant or planning to become pregnant during the course of the trial.
• Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
• Subject has osteomyelitis proximal to the phalanges. Osteomyelitis in the digit(s) of the target foot is permitted.
• Wounds must be confined to the foot below the ankle. Heel wounds are excluded.
• Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted.
• Recent myocardial infarction or stroke less than 90 days prior to the index procedure.
• Symptomatic acute heart failure NYHA class III or greater.
• Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
• Inability to tolerate dual antiplatelet and/or anticoagulation therapy.
• Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
• Known allergy to nitinol or nickel.
• Bypass surgery of the target vessel(s). Prior bypass above the level of the infrapopliteal arteries is permitted. Angiographic Exclusion Criteria
• Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of aneurysmal segments.
• Fractured or otherwise compromised stents in the target vessel or inflow vessel.
• In-stent restenosis in the target vessel.
• Previous treatment of inflow lesions performed less than or equal to 7 days prior to the index procedure.
• Previous treatment of the target vessel less than or equal to 90 days prior to index procedure.
• Angiographic evidence of thrombus within target limb.
• Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA.
• Type D dissections or greater incurred during CTO crossing (see Appendix I for definitions).
• Significant (greater than or equal to 50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.
• Distance from access to lesion is too long for a 135 cm working length of the Bare Temporary Spur Stent System catheter.
Inclusion Criteria:
• Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a witness, including a family member, sign on their behalf.
• Life expectancy greater than 1 year in the investigator's opinion.
• Male or non-pregnant female ≥18 years of age at time of consent.
• Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
• For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 3 days prior to the index procedure or greater than or equal to 7 days following the index procedure. Angiographic
Inclusion Criteria:
• Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed via the true lumen with a guidewire (no subintimal crossing).
• Iliac, SFA and popliteal inflow lesions can be treated using standard of care during the index procedure or greater than or equal to 3 days prior. Note:
• Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
• Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not fractured or otherwise compromised.
• Distal embolic protection is strongly encouraged in cases where atherectomy is used.
• Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
• Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting dissection, thrombus, or aneurysm by angiography.
• Target vessel(s) reconstitute(s) at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint. Note:
• If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
• If the peroneal artery is treated, there must be at least one collateral supplying the foot.
• In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries
• Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment.
• Target vessel reference diameter is measured to be between 2.5 to 4.5 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:
• Intravascular Ultrasound (IVUS) (primary)
• Visual estimate using Angiography (secondary)
• Target lesion length is less than or equal to 210mm in length. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm.
• Successful pre-dilatation of the target lesion defined as resulting in stenosis less than or equal to 50% and/or inner lumen diameter greater than or equal to 2.0 mm in diameter, without resulting flow limiting dissection, thrombus, or aneurysm by angiography prior to the insertion of the Bare Temporary Spur Stent System.
• Only one limb and one contiguous vessel may be enrolled per subject. If required, a second modality may be used for treatment in the non-target infrapopliteal vessel. Note:
• Distal embolic protection is strongly recommended in cases using atherectomy.
• Treatment of the target vessel/lesion may be performed only if treatment of the non-target lesion is successful without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography.
• Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion.
• If pre-screening with duplex ultrasound, angiography, CTA, or MRA has been performed less than or equal to 365 days prior to the procedure, intra-procedure angiography of the aorto-iliac vasculature is not required, however, the femoropopliteal inflow must still be imaged using angiography during the index procedure.
• Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the Bare Temporary Spur Stent System must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access. Pre-procedure
Exclusion Criteria:
• Subject unwilling or unlikely to comply with the 1-year duration of the study in the opinion of the investigator.
• Subject is pregnant or planning to become pregnant during the course of the trial.
• Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
• Subject has osteomyelitis proximal to the phalanges. Osteomyelitis in the digit(s) of the target foot is permitted.
• Wounds must be confined to the foot below the ankle. Heel wounds are excluded.
• Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted.
• Recent myocardial infarction or stroke less than 90 days prior to the index procedure.
• Symptomatic acute heart failure NYHA class III or greater.
• Impaired renal function (eGFR less than or equal to 25 mL/min) within 30 days of procedure or end stage renal disease on dialysis.
• Inability to tolerate dual antiplatelet and/or anticoagulation therapy.
• Known allergies or sensitivities to heparin, antiplatelet drugs, other anticoagulant therapies which could not be substituted, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• The subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
• Known allergy to nitinol or nickel.
• Bypass surgery of the target vessel(s). Prior bypass above the level of the infrapopliteal arteries is permitted. Angiographic Exclusion Criteria
• Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion. Inflow must also be free of aneurysmal segments.
• Fractured or otherwise compromised stents in the target vessel or inflow vessel.
• In-stent restenosis in the target vessel.
• Previous treatment of inflow lesions performed less than or equal to 7 days prior to the index procedure.
• Previous treatment of the target vessel less than or equal to 90 days prior to index procedure.
• Angiographic evidence of thrombus within target limb.
• Extremely severe calcification that, in the investigator's opinion, would not be amenable to PTA.
• Type D dissections or greater incurred during CTO crossing (see Appendix I for definitions).
• Significant (greater than or equal to 50%) stenosis of inflow arteries or unsuccessful treatment of inflow lesions.
• Distance from access to lesion is too long for a 135 cm working length of the Bare Temporary Spur Stent System catheter.
DEVICE: Bare Temporary Spur Stent System
Peripheral Arterial Disease, Critical Limb Ischemia
Peripheral Arterial Disease, Critical Limb Ischemia, Infrapopliteal Disease
Assessment of CCM in HF With Higher Ejection Fraction (AIM HIGHer)
Kenneth Alfieri - Kenneth.alfieri@prismahelath.org
ALL
18 years and over
NA
NCT05064709
Inclusion Criteria:
• Signed and dated informed consent form;
• Male or non-pregnant female, 18 years or older;
• Diagnosed with symptomatic heart failure;
• LVEF ≥40 and ≤70% (as assessed by site echo);
• A. Heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent OR B. If there is no heart failure hospitalization within 12 months prior to study consent OR an urgent heart failure visit requiring IV therapy within 6 months prior to study consent, an elevated BMI-adjusted natriuretic peptide value must be achieved (Refer to Table 1 in Section 9.2.6)
• Subjects must meet one of the following conditions: * Have stable, scheduled oral loop diuretic treatment (not just PRN) for a minimum of 30 days before providing study consent unless there is a documented allergy or intolerance. * Eligibility for enrollment is maintained for patients on an SGLT2 inhibitor without prescribed concurrent standing loop diuretic therapy if investigators provide instructions for a flexible PRN diuretic regimen (deemed appropriate by the clinician in response to symptoms or weight gain) Note: Stable is defined as no more than a 100% increase or 50% decrease in dose within the last 30 days. A one-time hold of diuretic dosing for 24 hours during the 30-day period is allowed and not an exclusionary event.
Exclusion Criteria:
• Resting ventricular rate \<50 or \>110 bpm;
• Resting systolic blood pressure \<100 or ≥160 mmHg;
• BMI greater than 46
• Any severe valvular stenotic disease or any severe valvular regurgitation;
• Mechanical tricuspid valve;
• Complex congenital heart disease;
• Exercise tolerance limited by a condition other than heart failure that, in the opinion of the investigator, contributes significantly to the primary symptoms of shortness of breath and/or exercise intolerance;
• Unable to walk at least 100 meters or walks more than 450 meters during a 6MWT;
• A KCCQ CCS score higher than 85;
• Hypertrophic, infiltrative/restrictive or inflammatory cardiomyopathy;
• Unstable angina pectoris within 30 days prior to study consent;
• Acute, decompensated heart failure requiring IV therapy or ultrafiltration within 30 days prior to consent, in the hospital or an outpatient setting;
• Receiving cardiac resynchronization therapy (CRT); NOTE: Subjects with active/ongoing cardiac resynchronization therapy (CRT) implanted more than one year ago are eligible for inclusion if they are currently classified as NYHA class III or higher.
• Scheduled for a cardiac surgery or a percutaneous cardiac intervention (PCI) or have undergone cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
• Myocardial infarction within 90 days prior to study consent;
• Prior heart transplant or ventricular assist device;
• Planning to become pregnant during the study;
• Dialysis (permanent) or GFR \<15 ml/min/1.73m2;
• Participating in another investigational drug or device study that may interfere with the interpretation of study data;
• Currently undergoing active chemotherapeutic and/or radiation treatment for cancer or has a history of chemotherapy during the 2-year period prior to study consent;
• Expected lifespan of less than 18 months from time of study consent;
• Unable to follow through study protocol for any reasons in the investigator's judgement.
DEVICE: Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System, DEVICE: OPTIMIZER™ Smart Mini System
Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction, Heart Failure With Moderately Reduced Ejection Fraction, Diastolic Heart Failure
HFpEF, Heart failure, CCM, CCM therapy, cardiac contractility modulation, symptomatic heart failure, left ventricular ejection fraction, LVEF, Optimizer, Optimizer Smart Mini, Quality of Life
Pounce™ Thrombectomy System Retrospective Registry (PROWL)
Clinical Program Manager - PROWLRegistry@surmodics.com
ALL
18 years and over
NCT05868161
Inclusion Criteria:
* Subject underwent an endovascular intervention where the Pounce Thrombectomy System was attempted
* Subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place
Exclusion Criteria:
* Subject is under the age of 18 years DEVICE: Pounce Thrombectomy System
Peripheral Arterial Disease, Acute Limb Ischemia
SYMPHONY-PE Study for Treatment of Pulmonary Embolism
Sylvie Akiel-Fu, MPH - safu@imperativecare.com
ALL
18 years to 80 years old
NA
NCT06062329
Inclusion Criteria:
• CTA evidence of acute PE within ≤14 days
• Clinical signs and symptoms consistent with acute PE.
• Systolic BP ≥90 mmHg with evidence of dilated RV with an RV/LV ratio \>0.9 (based on Investigator's assessment of RV/LV ratio)
• Stable heart rate \<130 BPM prior to procedure
• Subject is between 18 and 80 years of age
• Subject is willing to sign an IRB-approved informed consent form
• Subject is willing and able to comply with protocol follow-up
Exclusion Criteria:
• Thrombolytic use within 14 days of baseline CTA
• International Normalized Ratio (INR) \>3
• Platelets \<100,000/µL
• Kidney dysfunction as confirmed by serum creatinine \>1.8 mg/dL or GFR \<45 mL/min
• Hematocrit \<28% or hemoglobin \<9 g/dL
• Systolic BP \<90 mmHg for 15 min or requirement of inotropic support to maintain systolic BP ≥90 mmHg any time after admission
• Experienced cardiac arrest
• Has left bundle branch block
• Known bleeding diathesis or coagulation disorder
• Presence of intracardiac lead in the right ventricle or right atrium
• Presence of intracardiac thrombus
• Major trauma within the past 14 days
• Cardiovascular or pulmonary surgery within last 7 days
• Known serious, uncontrolled sensitivity to radiographic agents
• Contraindication to anticoagulants, i.e., heparin or alternative
• Patient on extracorporeal membrane oxygenation (ECMO)
• Cancer requiring active chemotherapy
• Heparin-induced thrombocytopenia (HIT)
• Pulmonary hypertension with peak pulmonary artery pressure \>70 mmHg by right heart catheterization.
• History of chronic severe pulmonary hypertension, and/or chronic left heart disease with left ventricular ejection fraction ≤30%
• Life expectancy \<90 days as determined by investigator
• Pregnant or nursing
• COVID-19 positive at hospital admission
• Current participation in another investigational study
• Evidence such as imaging or other that suggests the subject is not appropriate for this procedure (e.g., target vessel size is too small to accommodate 16F or 24F catheters).
DEVICE: Symphony Thrombectomy System
Acute Pulmonary Embolism, Thromboembolism, Emboli, Pulmonary, Thrombosis, Thrombus, Embolism, Embolism, Cardiovascular Diseases, Vascular Diseases
Thrombectomy, Submassive Pulmonary Embolism, Right Ventricle dysfunction
Direct Access Carotid Artery Stenting Using the Neuroguard IEP System (PERFORMANCE III)
Kya Spann - kya.spann@prismahealth.org
ALL
20 years to 80 years old
NA
NCT05845710
General Inclusion Criteria
• Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 or ≤ 80 years of age.
• Subject is willing and capable of complying with and understands all study protocol requirements, including the specified follow-up visits, and can be contacted by telephone.
• Subject has signed a written informed consent form that has been approved by the local governing Institutional Review Board (IRB) of the respective clinical site.
• Subject is diagnosed with carotid artery stenosis treatable with carotid artery stenting via direct carotid access and is considered a high operative risk for carotid endarterectomy (CEA).
• Subject is diagnosed with either:
• Symptomatic carotid stenosis ≥ 50% as determined by angiography, CTA, or duplex ultrasound. Symptomatic is defined as having stroke, transient ischemic attack (TIA) in the ipsilateral hemisphere supplied by the target vessel carotid lesion or ipsilateral transient monocular blindness (amaurosis fugax) within 180 days prior to the procedure; or
• Asymptomatic carotid stenosis ≥ 70% as determined by angiography, CTA, or duplex ultrasound.
• Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
• Subject has a modified Rankin Scale of ≤ 2 at the time of procedure.
• Females of child-bearing potential have a negative pregnancy test within 24 hours prior to the index procedure.
• Subject is willing and able to take dual anti platelet therapy for a minimum of 30 days following the index procedure.
• Subject meets at least one physiologic or one anatomic high-risk criteria. Anatomic High-Risk Conditions for CEA
• Target lesion at or above C2 (level of jaw). 2. Prior head and neck surgery in the region of the carotid artery. 3. Tracheostomy or tracheostoma. 4. Surgically inaccessible lesion or hostile neck which the investigator deems safe for direct carotid access including but not limited to:
• Prior neck irradiation
• Radial neck dissection
• Cervical spine immobility 5. Prior ipsilateral CEA. 6. Prior cranial nerve injury. 7. Severe tandem lesions. 8. Occlusion of the contralateral CCA or ICA. 9. Severe bilateral ICA stenosis. Physiological High-Risk Conditions for CEA
• Subject is ≥ 70 years of age (maximum 80 years) at the time of enrollment.
• Subject has NYHA Class III or IV congestive heart failure (CHF).
• Subject has chronic obstructive pulmonary disease (COPD) with FEV1 \< 50, on intermittent or chronic oxygen therapy, or a resting PO2 of ≤ 60 mmHg (room air). 4 Subject has left ventricular ejection fraction (LVEF) ≤ 35%. 5. Subject has angina class 3 or 4 or unstable angina. 6. Subject has a history of recent myocardial infarction (between 30 days and 6 weeks prior to index the procedure).
• Subject has coronary artery disease with two or more vessels with ≥ 70% stenosis.
• Subject has planned coronary artery bypass grafting (CABG) or peripheral vascular surgery between 31 and 60 days after index procedure.
• Subject has restenosis following a prior carotid endarterectomy (CEA). Angiographic Inclusion Criteria
• Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
• Single de novo or restenotic (post carotid endarterectomy \[CEA\]) target lesion or severe tandem lesions that can be covered by a single Neuroguard stent.
• Target lesion is treatable with a single stent of up to 40 mm in length.
• Index vessel diameter (segment covered by the mid-portion of the stent) is between 4.0 mm and 6.0 mm at the site of the target lesion.
• Distal vessel diameter at the site of Neuroguard filter deployment is between 4.0 mm and 7.0 mm.
• Distal common carotid artery diameter (segment covered by proximal portion of the stent) is between 4.0 mm and 8.0 mm.
• Sufficient landing zone exists in the cervical internal carotid artery distal to the target lesion to allow for the safe and successful deployment of the integrated Neuroguard filter.
• At least 5 cm of atherosclerosis free space in the ipsilateral common carotid artery between the sheath insertion site and the proximal edge of the target lesion.
• Common carotid artery reference diameter is at least 6 mm.
• Target vessel must meet diameter requirements as set forth in the Neuroguard IEP Direct System Instructions for Use (IFU). General Exclusion Criteria
• Life expectancy of less than one year in the opinion of the investigator at the time of enrollment.
• Currently requiring an organ transplantation.
• An evolving acute stroke
• Anticipated or existing potential sources of emboli including left ventricular aneurysm, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic patent foramen ovale (PFO), left atrial thrombus, any intracardiac mass.
• Deep being thrombosis (DVT) or pulmonary embolism (PE) treated within the past 12 months.
• Recently (\< 60 days) implanted heart valve.
• Subject has experienced any episode of paroxysmal atrial fibrillation or atrial flutter within the past 6 months or has a history of paroxysmal atrial fibrillation or atrial flutter requiring chronic anticoagulation.
• History of chronic atrial flutter or chronic atrial fibrillation.
• Anticoagulation with Phenprocoumon (Marcumar®), warfarin, direct thrombin inhibitors, or anti-Xa agents within 14 days of the index procedure.
• Subject with a known hypercoaguable state.
• Acute febrile illness (temperature ≥ 100.4°F or 38°C) or active infection.
• Subject with a SARS-CoV-2/COVID-19 infection within 21 days prior to the index procedure.
• Acute myocardial infarction \< 30 days prior to index procedure.
• Any major surgical procedure (i.e., intraabdominal or intrathoracic surgery or any surgery / interventional procedure involving cardiac or vascular system) 30 days prior to or within 30 days following the index procedure.
• History of disabling stroke with substantial residual disability (modified Rankin score ≥ 3).
• Subject has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to the index procedure.
• Known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days of the index procedure.
• Any other neurological deficit not due to stroke that may confound neurological assessments.
• Subject has contralateral laryngeal or vagus nerve injury.
• Subject has severe dementia.
• Subject has intracranial tumor.
• Known hypersensitivity to nitinol or its components (e.g., nickel, titanium).
• History of intracranial hemorrhage within the 12 months prior to the index procedure.
• History of gastrointestinal (GI) bleed within 30 days prior to the index procedure that would interfere with antiplatelet therapy.
• Any condition that precludes proper angiographic assessment or makes direct carotid artery access unsafe (e.g., severe hepatic impairment, malignant hypertension, morbid obesity).
• Subject has less than 5 cm between the direct carotid access site and the proximal edge of the target lesion.
• Known hypersensitivity to contrast media that cannot be adequately premedicated.
• Hemoglobin (Hgb) \< 8 gm/dL, platelet count \< 100,000, international normalized ratio (INR) \> 1.5 (irreversible), or heparin-induced thrombocytopenia.
• Subject has a serum creatinine \> 2.5 mg/dL on the day of the index procedure.
• History or current indication of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clotting time (ACT) at ≥ 250 seconds, or uncorrectable severe anemia.
• Contraindication, intollerance or allergy to standard of care study medications, including antiplatelet therapy or aspirin.
• Previously enrolled in this study or currently enrolled in another interventional device or drug study that has not yet reached the primary endpoint.
• Potential for subject non-compliance with protocol-required follow up or antiplatelet medication in the opinion of the investigator.
• Subject is otherwise unsuitable for intervention or surgery in the opinion of the investigator. Angiographic Exclusion Criteria
• Total occlusion of the target carotid artery.
• Previously placed stent in the target vessel or the planned arteriotomy site.
• Excessive circumferential calcification of the target lesion, defined as \> 3 mm of thickness of calcification seen in orthogonal views on fluoroscopy or on CTA.
• Qualitative characteristics of ipsilateral common carotid artery, ipsilateral external carotid artery, or target lesion that preclude or make difficult the safe introduction of the direct access sheath.
• Angiographic evidence of a mobile filling defect or fresh thrombus in the target carotid artery.
• Presence of "string sign" of the target lesion (a sub-totally occluded, long segment of the true lumen of the artery with markedly reduced contrast flow).
• Non-atherosclerotic carotid stenosis (e.g., dissection, fibromuscular dysplasia).
• Proximal/ostial CCA stenosis ≥ 50% or intracranial stenosis more severe than the target lesion.
• Subject in whom direct carotid access is not possible, including severe tortuosity or stenosis that requires additional endovascular procedures or that prevents safe and expeditious vascular access.
• Subject with intracranial pathology, that in the opinion of the investigator, makes the patient inappropriate for study participation (e.g., arteriovenous malformation, intracranial tumor, microangiopathy or large vessel cerebral vascular disease, etc.) or that would confound the neurological evaluation.
• Angiographic, CT, MR or ultrasound evidence of atherosclerosis of the common carotid artery that would preclude or make difficult safe placement of the sheath and other endovascular devices to the target artery as needed for carotid stenting.
• Angiographic, CT, MR or ultrasound evidence of severe tortuosity of the cervical internal carotid artery. Severe vascular tortuosity is defined as 2 or more bends of 90 degrees or more within 4 cm of the target lesion.
• Angiographic, CT, MR or ultrasound evidence of angulation or tortuosity (≥ 90 degree) of the common carotid artery (CCA) that will transmit a severe loop to the internal carotid after sheath placement.
• Subject with \> 50% stenosis in the common carotid artery (CCA) proximal to the target lesion.
• Male and non-pregnant, non-breastfeeding female subjects whose age is ≥ 20 or ≤ 80 years of age.
• Subject is willing and capable of complying with and understands all study protocol requirements, including the specified follow-up visits, and can be contacted by telephone.
• Subject has signed a written informed consent form that has been approved by the local governing Institutional Review Board (IRB) of the respective clinical site.
• Subject is diagnosed with carotid artery stenosis treatable with carotid artery stenting via direct carotid access and is considered a high operative risk for carotid endarterectomy (CEA).
• Subject is diagnosed with either:
• Symptomatic carotid stenosis ≥ 50% as determined by angiography, CTA, or duplex ultrasound. Symptomatic is defined as having stroke, transient ischemic attack (TIA) in the ipsilateral hemisphere supplied by the target vessel carotid lesion or ipsilateral transient monocular blindness (amaurosis fugax) within 180 days prior to the procedure; or
• Asymptomatic carotid stenosis ≥ 70% as determined by angiography, CTA, or duplex ultrasound.
• Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
• Subject has a modified Rankin Scale of ≤ 2 at the time of procedure.
• Females of child-bearing potential have a negative pregnancy test within 24 hours prior to the index procedure.
• Subject is willing and able to take dual anti platelet therapy for a minimum of 30 days following the index procedure.
• Subject meets at least one physiologic or one anatomic high-risk criteria. Anatomic High-Risk Conditions for CEA
• Target lesion at or above C2 (level of jaw). 2. Prior head and neck surgery in the region of the carotid artery. 3. Tracheostomy or tracheostoma. 4. Surgically inaccessible lesion or hostile neck which the investigator deems safe for direct carotid access including but not limited to:
• Prior neck irradiation
• Radial neck dissection
• Cervical spine immobility 5. Prior ipsilateral CEA. 6. Prior cranial nerve injury. 7. Severe tandem lesions. 8. Occlusion of the contralateral CCA or ICA. 9. Severe bilateral ICA stenosis. Physiological High-Risk Conditions for CEA
• Subject is ≥ 70 years of age (maximum 80 years) at the time of enrollment.
• Subject has NYHA Class III or IV congestive heart failure (CHF).
• Subject has chronic obstructive pulmonary disease (COPD) with FEV1 \< 50, on intermittent or chronic oxygen therapy, or a resting PO2 of ≤ 60 mmHg (room air). 4 Subject has left ventricular ejection fraction (LVEF) ≤ 35%. 5. Subject has angina class 3 or 4 or unstable angina. 6. Subject has a history of recent myocardial infarction (between 30 days and 6 weeks prior to index the procedure).
• Subject has coronary artery disease with two or more vessels with ≥ 70% stenosis.
• Subject has planned coronary artery bypass grafting (CABG) or peripheral vascular surgery between 31 and 60 days after index procedure.
• Subject has restenosis following a prior carotid endarterectomy (CEA). Angiographic Inclusion Criteria
• Subject has a lesion located in the internal carotid artery (ICA) and/or common carotid artery (CCA).
• Single de novo or restenotic (post carotid endarterectomy \[CEA\]) target lesion or severe tandem lesions that can be covered by a single Neuroguard stent.
• Target lesion is treatable with a single stent of up to 40 mm in length.
• Index vessel diameter (segment covered by the mid-portion of the stent) is between 4.0 mm and 6.0 mm at the site of the target lesion.
• Distal vessel diameter at the site of Neuroguard filter deployment is between 4.0 mm and 7.0 mm.
• Distal common carotid artery diameter (segment covered by proximal portion of the stent) is between 4.0 mm and 8.0 mm.
• Sufficient landing zone exists in the cervical internal carotid artery distal to the target lesion to allow for the safe and successful deployment of the integrated Neuroguard filter.
• At least 5 cm of atherosclerosis free space in the ipsilateral common carotid artery between the sheath insertion site and the proximal edge of the target lesion.
• Common carotid artery reference diameter is at least 6 mm.
• Target vessel must meet diameter requirements as set forth in the Neuroguard IEP Direct System Instructions for Use (IFU). General Exclusion Criteria
• Life expectancy of less than one year in the opinion of the investigator at the time of enrollment.
• Currently requiring an organ transplantation.
• An evolving acute stroke
• Anticipated or existing potential sources of emboli including left ventricular aneurysm, aortic or mitral mechanical heart valve, severe calcific aortic stenosis (valve area \< 1.0 cm2), endocarditis, moderate to severe mitral stenosis, known previously symptomatic patent foramen ovale (PFO), left atrial thrombus, any intracardiac mass.
• Deep being thrombosis (DVT) or pulmonary embolism (PE) treated within the past 12 months.
• Recently (\< 60 days) implanted heart valve.
• Subject has experienced any episode of paroxysmal atrial fibrillation or atrial flutter within the past 6 months or has a history of paroxysmal atrial fibrillation or atrial flutter requiring chronic anticoagulation.
• History of chronic atrial flutter or chronic atrial fibrillation.
• Anticoagulation with Phenprocoumon (Marcumar®), warfarin, direct thrombin inhibitors, or anti-Xa agents within 14 days of the index procedure.
• Subject with a known hypercoaguable state.
• Acute febrile illness (temperature ≥ 100.4°F or 38°C) or active infection.
• Subject with a SARS-CoV-2/COVID-19 infection within 21 days prior to the index procedure.
• Acute myocardial infarction \< 30 days prior to index procedure.
• Any major surgical procedure (i.e., intraabdominal or intrathoracic surgery or any surgery / interventional procedure involving cardiac or vascular system) 30 days prior to or within 30 days following the index procedure.
• History of disabling stroke with substantial residual disability (modified Rankin score ≥ 3).
• Subject has had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to the index procedure.
• Known severe carotid stenosis contralateral to the target lesion requiring treatment within 30 days of the index procedure.
• Any other neurological deficit not due to stroke that may confound neurological assessments.
• Subject has contralateral laryngeal or vagus nerve injury.
• Subject has severe dementia.
• Subject has intracranial tumor.
• Known hypersensitivity to nitinol or its components (e.g., nickel, titanium).
• History of intracranial hemorrhage within the 12 months prior to the index procedure.
• History of gastrointestinal (GI) bleed within 30 days prior to the index procedure that would interfere with antiplatelet therapy.
• Any condition that precludes proper angiographic assessment or makes direct carotid artery access unsafe (e.g., severe hepatic impairment, malignant hypertension, morbid obesity).
• Subject has less than 5 cm between the direct carotid access site and the proximal edge of the target lesion.
• Known hypersensitivity to contrast media that cannot be adequately premedicated.
• Hemoglobin (Hgb) \< 8 gm/dL, platelet count \< 100,000, international normalized ratio (INR) \> 1.5 (irreversible), or heparin-induced thrombocytopenia.
• Subject has a serum creatinine \> 2.5 mg/dL on the day of the index procedure.
• History or current indication of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin in amounts sufficient to maintain an activated clotting time (ACT) at ≥ 250 seconds, or uncorrectable severe anemia.
• Contraindication, intollerance or allergy to standard of care study medications, including antiplatelet therapy or aspirin.
• Previously enrolled in this study or currently enrolled in another interventional device or drug study that has not yet reached the primary endpoint.
• Potential for subject non-compliance with protocol-required follow up or antiplatelet medication in the opinion of the investigator.
• Subject is otherwise unsuitable for intervention or surgery in the opinion of the investigator. Angiographic Exclusion Criteria
• Total occlusion of the target carotid artery.
• Previously placed stent in the target vessel or the planned arteriotomy site.
• Excessive circumferential calcification of the target lesion, defined as \> 3 mm of thickness of calcification seen in orthogonal views on fluoroscopy or on CTA.
• Qualitative characteristics of ipsilateral common carotid artery, ipsilateral external carotid artery, or target lesion that preclude or make difficult the safe introduction of the direct access sheath.
• Angiographic evidence of a mobile filling defect or fresh thrombus in the target carotid artery.
• Presence of "string sign" of the target lesion (a sub-totally occluded, long segment of the true lumen of the artery with markedly reduced contrast flow).
• Non-atherosclerotic carotid stenosis (e.g., dissection, fibromuscular dysplasia).
• Proximal/ostial CCA stenosis ≥ 50% or intracranial stenosis more severe than the target lesion.
• Subject in whom direct carotid access is not possible, including severe tortuosity or stenosis that requires additional endovascular procedures or that prevents safe and expeditious vascular access.
• Subject with intracranial pathology, that in the opinion of the investigator, makes the patient inappropriate for study participation (e.g., arteriovenous malformation, intracranial tumor, microangiopathy or large vessel cerebral vascular disease, etc.) or that would confound the neurological evaluation.
• Angiographic, CT, MR or ultrasound evidence of atherosclerosis of the common carotid artery that would preclude or make difficult safe placement of the sheath and other endovascular devices to the target artery as needed for carotid stenting.
• Angiographic, CT, MR or ultrasound evidence of severe tortuosity of the cervical internal carotid artery. Severe vascular tortuosity is defined as 2 or more bends of 90 degrees or more within 4 cm of the target lesion.
• Angiographic, CT, MR or ultrasound evidence of angulation or tortuosity (≥ 90 degree) of the common carotid artery (CCA) that will transmit a severe loop to the internal carotid after sheath placement.
• Subject with \> 50% stenosis in the common carotid artery (CCA) proximal to the target lesion.
DEVICE: Neuroguard IEP Direct System
Carotid Stenosis, Carotid Artery Diseases
carotid artery stent
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure (TEAM-HF)
Abigail Anderson - Abigail.Anderson@prismahealth.org
ALL
18 years and over
NA
NCT06526195
Inclusion Criteria:
• Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure.
• LVEF ≤30% and Cardiac Index \< 2.2 L/min/m².
• Limited functional status as demonstrated by 6MWT \< 300 m due to HF related reasons.
• NYHA Class IIIB or NYHA Class IV
• Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months.
• Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant.
• Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group Randomization Criteria:
• Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
• Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
• mean PAP ≥ 30 mmHg.
• The patient will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant. Single Arm Registry Criteria: 1\. mean PAP \<30 mmHg
Exclusion Criteria:
• Subject is \< 18 years of age at the time of informed consent.
• Any use of inotrope therapy in the last 30 days.
• Contra-indications to HM3 LVAS or CardioMEMS HF system.
• Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, severe valvular heart disease, or restrictive cardiomyopathy.
• Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
• Existence of ongoing MCS.
• Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
• History of any solid organ transplant.
• Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
• Presence of an active, uncontrolled infection.
• Complex congenital heart disease.
• Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
• History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis.
• Planned VAD or Bi-VAD support prior to enrollment.
• Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:
• An INR ≥ 2.0 not due to anticoagulation therapy
• An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
• Biopsy proven liver cirrhosis.
• Need for chronic renal replacement therapy.
• History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted.
• History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis.
• Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• Any condition other than HF that could limit survival to less than 24 months.
• Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.
DEVICE: CardioMEMS HF System, DEVICE: HeartMate 3 Left Ventricular Assist System, OTHER: Guideline Medical Directed Therapy
Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension
Heart Failure, Left Ventricular Assist Device (LVAD), Guideline Directed Medical Therapy (GDMT), Non-inotrope Dependent, Pulmonary Artery Pressure, Hemodynamic Monitoring, Medical Management, CardioMEMS, HeartMate 3 (HM3), Ambulatory Advanced Heart Failure
Acoramidis Transthyretin Amyloidosis Prevention Trial in the Young (ACT-EARLY) Study in Asymptomatic Carriers of a Pathogenic TTR Variant
Medical Information - medinfo@eidostx.com
ALL
18 years to 75 years old
PHASE3
NCT06563895
Key
Inclusion Criteria:
* Male or female ≥ 18 to ≤ 75 years of age inclusive.
* Participants must have an established genotype (hetero- or homozygosity) of a TTR gene variant that is known to be pathogenic (eg, V30M/p.V50M, V122I/p.V142I, T60A/p.T80A, or any other pathogenic TTR variant(s)) confirmed by central laboratory prior to randomization.
* Participant's age is no more than 10 years (≤ 10) younger than the PADO.
Key Exclusion Criteria:
* Evidence of ATTR-CM or ATTR-PN.
* Presence of a TTR variant known to be phenotypically protective (eg, T119M, R104H).
* Current or past treatment with other TTR modifying therapies.
* Contraindication to or inability to undergo Cardiac magnetic resonance testing.
* Major organ dysfunction, including: kidney disease, liver disease, heart disease (including cardiomyopathy), neuropathy
* Other diseases or conditions such has cancer within 3 years, untreated hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis B or C, HIV.
* Major surgery within the past 3 months or planned during the next 12 months.
* Known hypersensitivity to acoramidis. DRUG: Acoramidis, DRUG: Placebo oral tablet
Amyloidosis, Amyloid Cardiomyopathy, Transthyretin Amyloidosis, Cardiomyopathies, Heart Diseases, Polyneuropathies
Amyloidosis, ATTR-CM, ATTR-PN, Transthyretin, Amyloid, TTR
MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions (MAGICAL ISR)
Lindsey Bentley - lindsey.bentley@prismahealth.org
ALL
18 years to 110 years old
NA
NCT05908331
Inclusion Criteria:
• Subject is at least 18 years old
• Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
• Patient with an indication for PCI due to suspected in-stent restenosis
• Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows: Angiographic
Inclusion Criteria:
• In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
• Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve \[FFR\] ≤0.80 or non-hyperemic pressure ratio \[NHPR\] ≤0.89) in absence of symptoms
• Successful lesion preparation (residual stenosis \<30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
• Target lesion in a native coronary artery
• Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
• Target reference vessel diameter (visual estimation) \>2.0 and ≤4.0 mm
• Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
• One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter \>2.0 mm)
• Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization
Exclusion Criteria:
General Exclusion Criteria (all must be absent for the patient to be eligible):
• STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
• NSTEACS in whom the biomarkers have not peaked
• PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
• Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
• Cardiogenic shock (defined as persistent hypotension \[systolic blood pressure \<90 mm Hg\] or requiring vasoactive or hemodynamic support, including IABP)
• Subject is intubated
• Known left ventricular ejection fraction \<30%
• Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
• Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
• If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
• Hemoglobin \<9 g/dL
• Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3
• White blood cell count \<3,000 cells/mm3
• Active infection undergoing treatment
• Clinically significant liver disease
• Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be \<30ml/min by the MDRD formula
• Active peptic ulcer or active bleeding from any site
• Bleeding from any site requiring active medical attention within the prior 8 weeks
• History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
• Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
• Known allergy to the study device components or protocol-required concomitant medications:
• sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated
• Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to \<24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
• Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
• Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
• Women who intend to become pregnant within 12 months after the index procedure
• Patient has received an organ transplant or is on a waiting list for an organ transplant
• Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
• Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):
• More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
• ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
• Unprotected left main lesions \>50% or left main intervention
• Primary PCI for STEMI
• Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
• Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
• Prior brachytherapy or DCB treatment of target lesion
• Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is \>2.0 mm
• Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
• Target lesion contains large thrombus
• Target lesion is heavily calcified
• Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.\* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.
• Diffuse distal disease to target lesion with impaired runoff
DEVICE: Sirolimus Drug Coated Balloon, DEVICE: Plan balloon Angioplasty (POBA)
In-Stent Restenosis, Cardiovascular Diseases, Coronary Artery Disease
Drug coated balloon, Sirolimus coated balloon, ISR, Magic Touch, SCB, Concept Medical, MAGICAL ISR
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome (LIBREXIA-ACS)
Study Contact - Participate-In-This-Study1@its.jnj.com
ALL
18 years and over
PHASE3
NCT05754957
Inclusion Criteria:
* Participants must have an index event that meets all 3 of the following criteria within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation myocardial infarction \[STEMI\], non-STEMI, or unstable angina \[UA\]), c) cardiac biomarker elevation (example, troponin I, troponin T, creatine kinase-MB \[CK-MB\]) above the upper limit of normal as determined by the local laboratory
* Participants must have at least 2 of the following risk factors:a) age 65 or older, b) diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis, intracranial artery stenosis, g) conservative management (that is, no percutaneous intervention \[PCI\] or CABG after index ACS event), h) Any one or more of the following high-risk angiographic features i) total stent length of greater than (\>) 30 millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with more than one stent, iv) calcified target lesion treated with atherectomy, v) treatment of obstructive left main or proximal left anterior descending artery for index ACS (or clinical diagnosis of an anterior STEMI)
* All female participants of childbearing potential must have a negative highly sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening
* A female participant must not be pregnant, breastfeeding, or planning to become pregnant until 4 days (5 half-lives) after the last dose of study intervention
Exclusion Criteria:
* MI secondary to ischemia due to either increased oxygen demand or decreased supply (Type 2 MI) or periprocedural MI as the index ACS event
* Planned CABG or staged PCI after randomization
* Any condition that requires chronic anticoagulation at the discretion of the investigator and/or local guidelines
* Conditions with a significant increased risk of bleeding (example, clinically significant bleeding within previous 3 months, known bleeding diathesis, et cetera) DRUG: Milvexian, OTHER: Placebo
Acute Coronary Syndrome
Assessment of Combined CCM and ICD Device in HFrEF (INTEGRA-D)
Kenneth Alfieri - kenneth.alfieri@prismahealth.org
ALL
18 years and over
NA
NCT05855135
Inclusion Criteria:
Individuals must meet all the following:
• Patient is aged 18 years or older;
• Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;
• Patient has HFrEF (LVEF ≤40%);
• Patient is on GDMT for heart failure;
• Patient has a Class I or Class II indication for an ICD
• Patient has a reasonable expectation of meaningful survival of \> 1 year;
• Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;
• Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
• Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;
• Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;
• Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;
• Prior heart transplant or ventricular assist device;
• Implanted mechanical tricuspid valve;
• PR interval greater than 375ms or advanced AV block;
• In situ S-ICD, pacemaker, or CRT device;
• Indicated for CRT;
• End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);
• Indicated for permanent bradyarrhythmia pacing;
• Unstable angina pectoris within 30 days prior to study consent;
• Pregnant or planning to become pregnant during the study;
• Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable.
• Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
DEVICE: OPTIMIZER® Integra CCM-D System (Treatment Arm)
Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation
Heart Failure, HFrEF, Stage C Heart Failure, Stage D Heart Failure, Defibrillation Efficacy Testing, Induced Ventricular Fibrillation, Ventricular fibrillation, Ventricular tachycardia, Implantable cardioverter defibrillator, Sudden cardiac arrest
SIMPLAAFY Clinical Trial (SIMPLAAFY)
Nicholas Caulder - Nicholas.Caulder@PrismaHealth.org
ALL
18 years and over
NA
NCT06521463
Inclusion Criteria:
* Subject is of legal age to participate in the study per the laws of their respective geography.
* Subject is an acceptable candidate for a WATCHMAN FLX Pro device per the approved Instructions for Use.
* Subject is deemed to be suitable for all protocol defined drug regimens in the control and both test arms.
* The subject or legal representative is able to understand and willing to provide written informed consent to participate in the trial.
* The subject is able and willing to return for required follow-up visits and examinations.
Exclusion Criteria:
* Subject's device implant procedure was aborted (i.e., failed implant).
* Subject has a device margin residual leak \> 0mm at time of implant.
* Occurrence of complications (major bleeding, systemic embolism, stroke, pericardial effusion requiring intervention) during the implant procedure, post-procedure, or prior to randomization.
* Subject has a contraindication to one of the three protocol defined drug regimens.
* Subject requires long-term anticoagulation therapy for reason other than AF-related stroke risk reduction or requires chronic P2Y12 inhibitor therapy.
* Subject has known history of severe liver disease including cirrhosis with a Child-Pugh classification C or D.
* Subject with known hypercoagulability disorder, mechanical heart valve, rheumatic heart disease, or recurrent deep vein thrombosis.
* Subject has intracardiac thrombus, LAA sludge, or dense spontaneous echo contrast (SEC) observed during pre-implant imaging.
* Subject has Modified Rankin Score of ≥ 3 at baseline.
* Subject has left ventricular ejection fraction (LVEF) \< 30%.
* Subject with known amyloid cardiomyopathy.
* Platelet count ≤ 100,000 x 109/L.
* Subject has an estimated glomerular filtration rate (eGFR) \< 30 ml/min (chronic kidney disease stage IV or V) or is on dialysis.
* Subject has a stroke (of any cause, whether ischemic or hemorrhagic) within 30 days prior to implant or prior to randomization.
* Subject has a documented myocardial infarction (MI) as either a non-ST elevation MI (NSTEMI) or as an ST-elevation MI (STEMI), with or without intervention, within 30 days prior to implant or prior to randomization.
* Subject had or is planning to have any cardiac or non-cardiac intervention or surgical procedure within 30 days prior to or 6-months after implant (including, but not limited to, cardioversion, percutaneous coronary intervention, cardiac ablation, cataract surgery, etc.).
* Subject has a major bleeding event per International Society on Thrombosis and Haemostasis (ISTH) definitions within the 30 days prior to implant or prior to randomization. Lack of resolution of related clinical sequelae or planned and pending interventions to resolve bleeding/bleeding source are a further exclusion regardless of timing of the bleeding event.
* Subject has an active bleed.
* Subject has a cardiac tumor.
* Subject has signs/symptoms of acute or chronic pericarditis.
* Subject has an active infection.
* There is evidence of tamponade physiology.
* Subject has New York Heart Association Class IV congestive heart failure at the time of implant or prior to randomization.
* Subject is currently enrolled in another investigational study, except if the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatment.
* Subject is of childbearing potential and is, or plans to become, pregnant during the time of the study.
* Subject has a documented life expectancy of less than 12 months. DEVICE: WATCHMAN FLX Pro LAAC Device
Atrial Fibrillation, Stroke, Bleeding
Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve System (FASTR-II) (IDE-G210258) (FASTR-II)
Annemarie Forrest - aforrest@reprievecardio.com
ALL
22 years and over
PHASE3
NCT06898515
Inclusion Criteria:
• Diagnosis of HF with expected hospitalization \>24 hours, with \>1 new or worsening symptom and \>2 physical examination, laboratory, or invasive findings of HF, and receiving or with plans to receive a HF-specific treatment
• ≥10 lb. (4.5 kg) above dry weight as estimated by health care provider.
• Current outpatient prescription for daily loop diuretic.
• Participants ≥ 22 years of age able to provide informed consent and comply with study procedures.
• Elevated risk of diuretic resistance, as indicated by at least one of the following: Baseline hypochloremia OR Urine output \<1L in the 6 hours following IV loop diuretic \>=40 mg furosemide equivalent OR Spot urine sodium \<100 mmol/L 1-2 hours after IV loop diuretic \>= 40 mg furosemide equivalent
Exclusion Criteria:
• Urologic issues that would predispose the participant to a high rate of urogenital trauma or infection with catheter placement or known inability to place a Foley catheter.
• Hemodynamic instability as defined by any of the following: sustained systolic blood pressure \<90 mmHg for \>15 minutes within the past 48 hours, use of IV vasopressors or inotropes within past 48 hours, and/or current or previous mechanical circulatory support within the last week.
• Uncontrolled arrhythmias defined as sustained HR \>130 beats/min for \>10 minutes within the past 48 hours.
• Severe lung disease with chronic home oxygen requirement \>2L/min.
• Acute infection with evidence of systemic involvement (e.g., clinically suspected infection with fever or elevated serum white blood cell count).
• Estimated glomerular filtration rate (eGFR) \<25 ml/min/1.73m2 (calculated with either MDRD or CKD-EPI) or current use of renal replacement therapy (RRT).
• Significant left ventricular outflow obstruction, severe uncorrected complex congenital heart disease, known severe stenotic valvular disease, severe infiltrative or constrictive cardiomyopathy or other diagnosis that would make aggressive decongestion unsafe.
• Current or recent (\< 30 days) type I myocardial infarction (e.g., acute coronary syndrome such as NSTEMI or STEMI from plaque rupture), coronary artery bypass surgery, or stroke. An isolated troponin elevation (e.g., from volume overload or demand ischemia) is not a reason for exclusion.
• Severe electrolyte abnormalities (e.g., serum potassium \<3.0 mEq/L, magnesium \<1.3 mEq/L or sodium \<125 mEq/L). Note: These are based on baseline/screening labs. Participants whose electrolyte levels are repleted cannot be reassessed for inclusion in the trial.
• Other concomitant disease or condition the investigator believes will make it difficult to follow instructions or comply with study procedures and/or follow-up visits, including expected prolonged hospitalization for reasons other than decongestive therapy
• Currently enrolled in an interventional trial (observational studies are permitted).
• Life expectancy less than 6 months.
• Women who are pregnant or breastfeeding.
DEVICE: Reprieve System, DRUG: furosemide infusion
Acute Decompensated Heart Failure
DORAYA-HF Early Feasibility Study
Regina Maharajh - Regina.Maharajh3@prismahealth.org
ALL
18 years and over
NA
NCT05206422
INCLUSION.
• Subject is \>18 years of age.
• Subject is hospitalized with primary diagnosis of ADHF.
• N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
• Evidence of fluid overload as indicated by 2 or more of the following criteria:
• peripheral edema ≥ 2+
• radiographic pulmonary edema or pleural effusion
• enlarged liver or ascites
• pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
• Jugular venous distention \> 7 cmH2O
• IVCCI \< 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
• Subject insufficiently responds to IV diuretic therapy defined as average hourly urine output \<125ml/hour over 6 hours OR cumulative urine output \< 3L over 24 hours OR a Net Fluid Loss \<375mL in a 12-hour timeframe following ≥2 diuretic challenges with a minimum of:
• 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
• 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.
• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study. Females of child-bearing potential must have a negative pregnancy test. Procedural Inclusion Criterion
• CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter. EXCLUSION
• Systolic blood pressure \<90 mmHg at the time of screening.
• Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
• Known LVEF \< 10% by echocardiography within 1 year prior to enrollment.
• Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
• Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
• Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
• Subject has severe renal dysfunction, defined as either eGFR \<25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
• Subject with advanced liver disease: either Total Bilirubin \> 4 mg/dL or Serum sodium (corrected for glucose) \< 125 mmol/L.
• Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose is defined as \> 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit.
• Subject with a history of:
• Deep vein thrombosis that occurred \< 6 months prior to enrollment, and/or;
• Pulmonary embolism episode that occurred \< 6 months prior to enrollment.
• Evidence of active systemic infection documented by either one of the following: fever \>38°C/100°F, or ongoing uncontrolled infection (i.e. inflammatory parameters not decreasing despite \> 48 hrs of antibiotic treatment).
• Subjects with a known infra-renal IVC diameter of \<16mm.
• Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
• Subject is \>18 years of age.
• Subject is hospitalized with primary diagnosis of ADHF.
• N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,000 pg/m or BNP≥250 pg/mL for body-mass index (BMI) ≤25.
• Evidence of fluid overload as indicated by 2 or more of the following criteria:
• peripheral edema ≥ 2+
• radiographic pulmonary edema or pleural effusion
• enlarged liver or ascites
• pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
• Jugular venous distention \> 7 cmH2O
• IVCCI \< 50% by cardiac ultrasonography or elevated CVP (or RAP) ≥12 mmHg (Invasively measured).
• Subject insufficiently responds to IV diuretic therapy defined as average hourly urine output \<125ml/hour over 6 hours OR cumulative urine output \< 3L over 24 hours OR a Net Fluid Loss \<375mL in a 12-hour timeframe following ≥2 diuretic challenges with a minimum of:
• 1st diuretic dose: ≥2X chronic oral daily dose (IV) or 80 mg IV Lasix or equivalent.
• 2nd diuretic dose: ≥ 80 mg IV Lasix or equivalent.
• Females who are not pregnant or lactating and not planning to become pregnant for the duration of the study. Females of child-bearing potential must have a negative pregnancy test. Procedural Inclusion Criterion
• CVP (or RAP) ≥12 mmHg and PCWP ≥ 18 mmHg confirmed in the Cath Lab, via femoral line, pigtail, Swan Ganz, or other indwelling catheter. EXCLUSION
• Systolic blood pressure \<90 mmHg at the time of screening.
• Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleurocentesis within past 14 days or cardiovascular intervention within past 14 days.
• Known LVEF \< 10% by echocardiography within 1 year prior to enrollment.
• Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
• Known active myocarditis, hypertrophic obstructive cardiomyopathy, infiltrative cardiomyopathy (e.g., amyloidosis), constrictive pericarditis or cardiac tamponade.
• Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \\severe regurgitation) or Severe mitral disease with planned intervention.
• Subject has severe renal dysfunction, defined as either eGFR \<25 ml/min/1.73 m2 BSA on admission or on renal replacement therapy.
• Subject with advanced liver disease: either Total Bilirubin \> 4 mg/dL or Serum sodium (corrected for glucose) \< 125 mmol/L.
• Treatment with high dose IV inotropes within 2 days prior to enrollment. High dose is defined as \> 1 unit of inotrope (excluding Digoxin) as follows: 5 µg/kg/min dopamine = 1 unit, 5 µg/kg/min dobutamine= 1 unit, 0.375 µg/kg/min milrinone = 1 unit.
• Subject with a history of:
• Deep vein thrombosis that occurred \< 6 months prior to enrollment, and/or;
• Pulmonary embolism episode that occurred \< 6 months prior to enrollment.
• Evidence of active systemic infection documented by either one of the following: fever \>38°C/100°F, or ongoing uncontrolled infection (i.e. inflammatory parameters not decreasing despite \> 48 hrs of antibiotic treatment).
• Subjects with a known infra-renal IVC diameter of \<16mm.
• Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
DEVICE: Doraya Catheter
Acute Decompensated Heart Failure
ADHF