Ancora Heart has announced enrolment 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 (HFrEF). The study is being conducted to support the submission of a Premarket Approval (PMA) application to the US Food and Drug Administration (FDA).
“In patients with heart failure, the left ventricle often becomes enlarged as it has to work harder than a healthy heart to pump blood throughout the body,” said Ulrich Jorde, global co-principal investigator of the CORCINCH-HF Study; professor of medicine, Albert Einstein College of Medicine; and section head of Heart Failure, Cardiac Transplantation and Mechanical Circulatory Support at Montefiore Health System, New York, USA. “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.”
The CORCINCH-HF Study is a prospective, randomised, open-label, multicentre, international, clinical safety and efficacy investigation of the AccuCinch system, which is designed to enrol 400 patients at up to 80 centres worldwide. The study has a design allowing initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached 12 months of follow-up.
The AccuCinch system is designed to augment the existing care cardiologists provide their HF patients. For patients in whom HF has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch system may provide an effective treatment option by filling the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant, Ancora Heart said.
“The ability to offer additional treatment options to heart failure patients whose disease has progressed to the point that optimal medical therapy is no longer able to manage the symptoms is imperative,” said Jason R Foerst, medical director of the Carilion Clinic Structural Heart and Valve Program and assistant professor of medicine at Virginia Tech Carilion School of Medicine, Roanoke, USA, whose team enrolled the first patient in the CORCINCH-HF Study. “My team and I are excited to be a part of the CORCINCH-HF Study and look forward to working with Ancora Heart to fulfil our role in this very important clinical trial.”
During the minimally invasive AccuCinch 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 heart failure, Ancora Heart added in a statement.
“We look forward to working with our clinical partners to conduct the CORCINCH-HF study and together move closer to improving treatment options for the millions of people suffering from heart failure,” said Jeff Closs, president and CEO of Ancora Heart. “Previously collected data on early feasibility implants suggest that the AccuCinch System may afford significant clinical benefits to patients suffering from heart failure with reduced ejection fraction. We anticipate that the data from this study will confirm and expand upon these early findings and enable us to ultimately provide an important innovation that may halt or even reverse the progression of heart failure in many patients.”