First Enrollment Milestone Reached in Heart Failure Trial

Ancora Heart Inc. has reached the first enrollment milestone in its CORCINCH-HF trial evaluating the AccuCinch Transcatheter Left Ventricular Restoration System in heart failure (HF) patients with reduced ejection fraction (HFrEF). Six-month follow-up data on these 250 patients will support the company’s Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA).

The AccuCinch System is an investigational device designed to reduce the left ventricle size, reduce ventricular wall stress, and support and strengthen the heart wall. Early clinical study results were presented at the 2023 Technology and Heart Failure Therapeutics conference and simultaneously published in the Journal of Cardiac Failure. The AccuCinch System was granted Breakthrough Device Designation from the FDA in 2022.

“The AccuCinch System is the only completely transcatheter procedure to treat the enlarged left ventricle,” Ancora Heart President/CEO Jeff Closs said. “Reaching this milestone is an incredible accomplishment in heart failure research and a model example of collaboration across heart failure and structural heart care teams at participating CORCINCH-HF clinical trial sites. We’d like to thank study investigators for their commitment to innovation and partnership, and we look forward to building on this momentum as we work toward reaching our full enrollment target of 400 patients.”

The CORCINCH-HF study is evaluating the safety and effectiveness of the AccuCinch System in patients suffering from symptomatic HF with reduced ejection fraction. An estimated 6.7 million adults in the U.S. live with heart failure, and about half have HFrEF.^1,2

“Despite advances in guideline-directed medical therapy, many patients with heart failure continue to experience debilitating symptoms,” said Ulrich Jorde, M.D., CORCINCH-HF study global co-principal investigator, professor of medicine, Albert Einstein College of Medicine, 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.”

An estimated 6.7 million U.S. adults live with heart failure, a condition in which the heart’s muscles weaken and lose their ability to pump enough oxygen-rich blood to the body.^1,2 Heart failure patients suffer from debilitating symptoms, including persistent exhaustion, trouble breathing and confusion, as well as frequent hospitalizations. About half of HF patients have heart failure with a reduced ejection fraction (HFrEF) and an enlarged left ventricle, the heart’s main pumping chamber, which causes more stress on the heart and leads to reduced pumping efficiency. Up to 50% of people who develop heart failure die within five years of diagnosis.³

“AccuCinch is a device-based therapy aimed at reverse remodeling of the enlarged left ventricle,” said Mark Reisman, M.D.*, CORCINCH-HF study global co-principal investigator, director of structural heart disease at NewYork-Presbyterian/Weill Cornell Medical Center and co-director of structural heart disease for NewYork-Presbyterian Queens and NewYork-Presbyterian Brooklyn Methodist Hospital, who was recruited to Weill Cornell Medicine as a professor of medicine. “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 AccuCinch System is an investigational device that augments the existing care cardiologists provide their heart failure patients. For patients in whom HF has progressed beyond the ability of medications and pacemakers to manage symptoms, the AccuCinch System may provide a new treatment option to fill the gap between medication or pacemaker therapy and left ventricular assist devices (LVADs) or a heart transplant. During the minimally invasive AccuCinch System procedure, a flexible implant is attached to the left ventricle’s inner wall and then cinched.

The CORCINCH-HF study is a prospective, randomized, open-label, multicenter, international, clinical safety and effectiveness investigation of the AccuCinch Transcatheter Left Ventricular Restoration System, and is designed to enroll 400 patients worldwide. The study allows for initial analysis of safety and clinical effectiveness 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. 

Ancora Heart is a privately held medical device company providing new treatment options for people with heart failure. The Santa Clara, Calif.-based company’s lead product is the AccuCinch Transcatheter Left Ventricular Restoration System, an investigational device. 

* Dr. Reisman reports travel support from Ancora Heart.

References
¹ Martin SS, Aday AW, Almarzooq ZI, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee; Stroke Statistics Subcommittee. 2024 heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. 2024;149:e347–913.
² Murphy S, Ibrahim N, Januzzi J.  Heart Failure with Reduced Ejection Fraction, A Review.  JAMA. 2020;324(5):488-504
³ Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Association. Circulation. 2020;141(9):e139-596.