Ancora Heart announced it has reached the first enrollment milestone in its CORCINCH-HF pivotal trial evaluating the AccuCinch Transcatheter Left Ventricular Restoration System for patients with heart failure with reduced ejection fraction (HFrEF).
The trial has now enrolled 250 randomized patients. Data collected at six months will support the company’s planned premarket approval (PMA) submission to the FDA. Enrollment will continue until a total of 400 patients are enrolled.
The AccuCinch system is an investigational, catheter-based device designed to reduce the size of the left ventricle, decrease wall stress and support heart wall structure. The device is intended for patients whose condition has progressed beyond the benefits of guideline-directed medical therapy and who are not candidates for ventricular assist devices or heart transplantation. It received FDA breakthrough device designation in 2022.
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“The AccuCinch System is the only completely transcatheter procedure to treat the enlarged left ventricle,” President and CEO Jeff Closs said in a news release. “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.”
The CORCINCH-HF study is a prospective, randomized, multicenter investigation enrolling patients at sites worldwide. The trial is designed for an initial safety and effectiveness analysis after the first 250 patients complete a six-month follow-up, with a final analysis conducted after all 400 patients have completed 12 months.
“Despite advances in guideline-directed medical therapy, many patients with heart failure continue to experience debilitating symptoms,” said Dr. Ulrich Jorde, global co-principal investigator of the trial and section head of heart failure and transplantation at Montefiore Health System. “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.”
