First-in-Human Use of the AccuCinch Device for LV Restoration in HFrEF: CORCINCH-HF Trial Begins.
First-in-Human Use of the AccuCinch Device for LV Restoration in HFrEF: CORCINCH-HF Trial Begins.
Transcatheter Device Targets LV Remodeling in HFrEF, Marking a New Direction in Structural Heart Failure Therapies
Overview:
Announced in a clinical release dated June 23, 2025, as part of ongoing coverage of the CORCINCH-HF pivotal trial, the first patient has been treated using the investigational AccuCinch Ventricular Restoration System.
Key Scientific Highlights:
1. Study Name:
CORCINCH-HF – a U.S. pivotal trial evaluating a novel transcatheter therapy for patients with heart failure with reduced ejection fraction (HFrEF).
2. Device:
AccuCinch Ventricular Restoration System (Ancora Heart, Inc.), designed to reduce LV size, lower wall stress, and improve myocardial function.
3. Mechanism:
Aims to achieve reverse remodeling of the enlarged left ventricle using a transcatheter approach rather than surgery or pharmacologic therapy.
4. Milestone:
First patient successfully treated in the U.S. Trial will enroll 250 randomized symptomatic HFrEF patients.
5. Trial Leadership:
Dr. Ulrich Jorde (Montefiore Health System, affiliated with Albert Einstein College of Medicine)
Dr. Mark Reisman (Weill Cornell Medical Center, affiliated with Cornell University)
6. Regulatory Status:
Granted FDA Breakthrough Device Designation in 2022.
7. Preliminary Data:
Early results presented at THT 2023 and published in the Journal of Cardiac Failure showed favorable safety and feasibility.
8. Next Steps:
Six-month follow-up data will support the PMA submission to the FDA. Trial endpoints include safety, structural remodeling, symptom improvement, and hospitalization reduction.
9. Significance:
AccuCinch is the first transcatheter device specifically targeting LV restoration in HFrEF patients unresponsive to guideline-directed medical therapy.