CORCINCH-HF
The international CORCINCH-HF study evaluates whether a new device-based approach improves heart function and quality of life in patients with heart failure and reduced ejection fraction.
About This Study
Summary
Currently, 1 in 5 people is at risk of developing heart failure (HF) at some point in their lifetime. In roughly 50% of the total HF population (that is, those with HFrEF), the lower left chamber (left ventricle) of the heart is enlarged and doesn’t work well. That means the amount of blood pumped out of the heart is less than the body needs. Typical symptoms of HFrEF include persistent tiredness, trouble breathing, fluid retention, confusion, and memory loss.
CORCINCH-HF evaluates the safety and efficacy of a new device-based approach for treating HFrEF. Instead of requiring traditional open-chest heart surgery, the new device is delivered through a catheter to the left ventricle. Together, the study device and approach are designed to improve heart function, reduce heart failure symptoms, and enhance quality of life. All participants in CORCINCH-HF will receive guideline-directed medical therapy for HFrEF. In addition, participants are assigned randomly (50:50, like a coin toss) to receive the new device or not. Neither the lead scientist nor participants can choose which study treatment they get. Participants will have a study follow-up visit every 6 months for the first 2 years and then annually afterward, for a total of 5 years (7 follow-up visits) of involvement.
To be included in CORCINCH-HF, participants must be / have
- Adult (18 years or older)
- Ejection fraction of 20% to 40%
- 6-minute walk test distance of 100 to 450 m
- Established and stable guideline-directed medical therapy for heart failure
To be included in CORCINCH-HF, participants must not be / have
- Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 90 days prior to screening
- Untreated clinically significant coronary artery disease
- Heart failure other than ischemic or nonischemic dilated cardiomyopathy
- History of any stroke within 90 days before screening or documented disability from prior stroke
Keywords
Heart failure; Reduced ejection fraction; Structural heart disease
For More About This Study or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Jason Foerst, MD, is the medical director of the Structural Heart and Valve Center at Carilion Clinic, assistant professor of medicine at Virginia Tech Carilion School of Medicine, and director of Carilion's structural heart disease fellowship program. Dr. Foerst is a structural interventional cardiologist and researcher who completed his internship, residency, and fellowship training at Dartmouth–Hitchcock/Mary Hitchcock Memorial Hospital.
Official title of study
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
Funding mechanism
Industry sponsored by Ancora Heart, Inc.