StudyFinder
Search Results Within Category "Heart & Vascular"
7 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)
Rebecca Rebain - rebecca.rebain@prismahealth.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 ≤60% (as assessed by echo core lab);
• 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, AND elevated BMI-adjusted natriuretic peptide values (Refer to Table A in Section 9.2.6) 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 B in Section 9.2.6)
• Subjects must be on stable, scheduled oral loop diuretic treatment (not only PRN) for at least 30 days prior to study consent, unless documented allergy/intolerance. 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);
• 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 \<20 ml/min/1.73m2;
• Participating in another investigational study;
• 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;
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