Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With… (NCT04331769) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With Symptomatic Heart Failure With Reduced Ejection Fraction (HFrEF): The CORCINCH-HF Study
United States400 participantsStarted 2020-12-21
Plain-language summary
Prospective, randomized, open-label, international, multi-center clinical study to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18-years or older
✓. Ejection Fraction: ≥20% and ≤40% measured by transthoracic echocardiography (TTE) and assessed by an echocardiography (echo) core lab
✓. LV end-diastolic diameter ≥55 mm measured by TTE and assessed by an echo core lab
✓. Symptom Status:
✓. NYHA III,
✓. NYHA ambulatory IV, or
✓. NYHA II with a heart failure hospitalization within the prior 12 months (of signing the consent)
✓. Able to complete six-minute walk test with distance between 100 m and 450 m.
Exclusion criteria
✕. Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to consent
✕. Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
✕. Suboptimal ventricular anatomy or wall thickness as determined from screening echocardiography and/or CT scan
✕. Heart failure on the basis other than ischemic or non-ischemic dilated cardiomyopathy (e.g., hypertrophic cardiomyopathy, amyloid cardiomyopathy, restrictive cardiomyopathy, uncorrected congenital heart disease, constrictive pericarditis)
What they're measuring
1
Freedom from device- or femoral artery access-related major adverse events (MAE)
Timeframe: 180 days
2
Change from baseline in Kansas City Cardiomyopathy Questionnaire Quality of Life Questionnaire (KCCQ) Score
Timeframe: 180 days
3
6-Minute Walk Test (6MWT) distance (m)
Timeframe: 180 days
4
Freedom from device- or femoral artery access-related major adverse events (MAE)
Timeframe: 365 days
5
A hierarchical composite endpoint of all-cause deaths, left ventricular assist device (LVAD) implants or heart transplants, heart failure hospitalizations, and changes from baseline in Kansas City Cardiomyopathy Questionnaire Overall Score (KCCQ-OS)