CORCINCH-HF Pivotal Trial of Ancora Heart’s AccuCinch Reaches Enrollment Milestone

June 23, 2025—Ancora Heart, Inc. announced that it has reached the first enrollment milestone of 250 patients in the prospective, randomized, open-label, multicenter, international CORCINCH-HF pivotal trial of the company’s AccuCinch transcatheter left ventricular restoration system.

The company stated that the study is designed to allow an initial analysis of safety and clinical effectiveness of the device for premarket approval submission to the FDA after the first 250 patients have reached 6 months of follow-up; a second analysis will be submitted after the entire cohort of 400 patients has reached 12 months of follow-up.

According to the company, the CORCINCH-HF trial is evaluating the AccuCinch system to treat patients with heart failure with reduced ejection fraction. The AccuCinch system, which is an investigational device, is designed to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall, noted Ancora Heart.

In March 2023, the company announced that the results from early clinical studies were presented at THT 2023, the Technology and Heart Failure Therapeutics conference, and simultaneously published by Nadira Hamid, MD, et al in the Journal of Cardiac Failure. The AccuCinch system was granted FDA Breakthrough Device designation in 2022.

Ulrich Jorde, MD, and Mark Reisman, MD, are global coprincipal investigators of the CORCINCH-HF study.

“Despite advances in guideline-directed medical therapy, many patients with heart failure continue to experience debilitating symptoms,” commented Dr. Jorde in the company’s press release. “Reaching this milestone in the CORCINCH-HF study is a significant step toward determining whether this treatment option may improve the length and quality of their lives.”

Dr. Reisman added, “AccuCinch is a device-based therapy aimed at reverse remodeling of the enlarged left ventricle. This trial is designed to evaluate the safety of the device and procedure and whether we can improve heart structure and function and thereby help patients feel better, avoid hospitalizations and live longer.”