Clinical Evaluation of the AccuCinch® Ventricular Restoration System in Patients Who Present With… (NCT04331769) | Clinical Trial Compass
SuspendedNot 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
Stopped: Recruitment on hold pending modifications to the clinical investigation plan
United States, Belarus, Belgium400 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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)