Ancora Heart this week said it has enrolled the first patient in its AccuCinch Ventricular Restoration System pivotal trial.
AccuCinch is a flexible implant that is attached to the inner wall of the left ventricle and then cinched. It is designed to reduce the size of the left ventricle, reduce ventricular wall stress and support and strengthen the heart wall.
The Corcinch-HF pivotal trial will evaluate the safety and efficacy of the system in patients who have symptomatic heart failure with reduced ejection fraction. The study is being conducted to support the company’s premarket approval application for the FDA.
AccuCinch is touted as being one of the only completely transcatheter procedures to treat the enlarged left ventricle. It differs from device-based therapies that are designed to improve the structure and function of the heart to bring relief to heart failure patients who are still symptomatic.
“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,” Ulrich Jorde, global co-principal investigator of the Corcinch-HF study, said in a news release. “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 prospective, randomized, open-label, multi-center, international study will enroll 400 patients at up to 80 centers globally. It will allow for the initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up. The second analysis will occur after all patients have reached 12 months of follow-up.
Ancora Health said the AccuCinch System will health cardiologists augment existing care for heart failure patients and could provide an effective treatment option by filling the gap between medication or pacemaker therapy and left ventricular assist devices or heart transplants.
“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,” Jason Foerst, medical director of the Carilion Clinic Structural Heart and Valve Program and assistant professor of medicine at Virginia Tech Carilion School of Medicine, said. “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.”
“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,” Ancora Heart president and CEO Jeff Closs said. “Previously collected data on early feasibility implants suggests 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.”
