First 250 patients enrolled in transcatheter heart failure device trial to reduce LV size
The CORCINCH-HF U.S. pivotal trial, which is evaluating the AccuCinch Transcatheter Left Ventricular Restoration System (from Ancora Heart Inc.) in patients with heart failure with reduced ejection fraction (HFrEF), has reached its first enrollment milestone of 250 enrolled participants
The AccuCinch System is an investigational device designed to reduce the size of the left ventricle, reduce ventricular wall stress, and support and strengthen the heart wall. Results from early clinical studies were presented at the 2023 Technology and Heart Failure Therapeutics conference in March and simultaneously published in the Journal of Cardiac Failure.[1] The device was granted FDA Breakthrough Device Designation in 2022.
“Despite advances in guideline-directed medical therapy, many patients with heart failure continue to experience debilitating symptoms,” said Ulrich Jorde, MD, global co-principal investigator of the CORCINCH-HF Study and section head of heart failure, cardiac transplantation and mechanical circulatory support at Montefiore Health System in New York. “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.”
The CORCINCH-HF study is evaluating the safety and effectiveness of the AccuCinch System in patients who have symptomatic HF with reduced ejection fraction.
“AccuCinch is a device-based therapy aimed at reverse remodeling of the enlarged left ventricle,” added Mark Reisman, MD, global co-principal investigator of the study and the director of structural heart disease at NewYork-Presbyterian/Weill Cornell Medical Center. “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.”
The six-month follow-up data on 250 randomized patients will support the company’s premarket approval (PMA) submission to U.S. Food and Drug Administration (FDA). The company said enrollment will continue to 400 patients.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]