CORCINCH-HF Pivotal Trial Begins for Ancora Heart’s AccuCinch System

January 28, 2021—Ancora Heart, Inc. announced enrollment of the first patient in the CORCINCH-HF pivotal trial, which is designed to evaluate the safety and efficacy of the AccuCinch ventricular restoration system in patients who have symptomatic heart failure (HF) with reduced ejection fraction. This study is being conducted to support the submission of the company’s premarket approval (PMA) application to the FDA.

According to the company, the CORCINCH-HF study is a prospective, randomized, open-label, multicenter, international, clinical safety, and efficacy investigation of the AccuCinch system. The study is designed to enroll 400 patients at up to 80 centers worldwide. The study will allow initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached 6 months of follow-up and then a second analysis after the entire cohort has reached 12 months of follow-up.

The transcatheter AccuCinch system is designed to treat the enlarged left ventricle by improving the structure and function of the heart and help bring relief to HF patients who remain symptomatic despite current guideline-directed medical care. During the minimally invasive AccuCinch system procedure, a flexible implant is attached to the inner wall of the left ventricle and then cinched.

The implant is intended to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall. The AccuCinch system may enable improved functional capacity and quality of life for patients and potentially slow or reverse the left ventricular remodeling associated with the progression of HF, noted Ancora Heart.

“In patients with HF, the left ventricle often becomes enlarged as it has to work harder than a healthy heart to pump blood throughout the body,” commented Ulrich Jorde, MD, in the company’s announcement. Dr. Jorde serves as global Coprincipal Investigator of the CORCINCH-HF study. Dr. Jorde continued, “By providing structural support to the ventricle with the AccuCinch system, we aim to evaluate if the ventricle will be able to pump more efficiently and help to reduce the symptoms of the disease in these patients.”

Dr. Jorde is Professor of Medicine at Albert Einstein College of Medicine and Section Head of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support at Montefiore Health System in New York, New York.

The first patient in the study was enrolled by a team led by Jason R. Foerst, MD, Medical Director of the Carilion Clinic Structural Heart and Valve Program and Assistant Professor of Medicine at Virginia Tech Carilion School of Medicine in Roanoke, Virginia.

Dr. Foerst commented, “The ability to offer additional treatment options to HF patients whose disease has progressed to the point that optimal medical therapy is no longer able to manage the symptoms is imperative. My team and I are excited to be a part of the CORCINCH-HF study and look forward to working with Ancora Heart to fulfill our role in this very important clinical trial.”