CorCinch-EU
Research type
Research Study
Full title
Safety and Performance Evaluation of the AccuCinch® Ventricular Repair System for the treatment of heart failure with or without Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy
IRAS ID
230127
Contact name
Robert Smith
Contact email
Sponsor organisation
Ancora Heart, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
Heart failure (HF) has been singled out as an epidemic and is a staggering clinical and public health problem, associated with significant mortality, morbidity, and healthcare expenditures, particularly among those aged ≥65 years. After the diagnosis of HF, survival estimates are 50% and 10% at 5 and 10 years, respectively, and left ventricular dysfunction is associated with an increase in the risk of sudden death. Mitral regurgitation (MR) severity and left ventricular (LV) dilation are key predictors of cardiac mortality.
Up to 25 international investigation sites will participate in this study. Sites to be included in the study will meet study qualification requirements for investigators’ experience and site infrastructure, and have received all necessary institutional review board/ethics committee and regulatory approvals.
A maximum of 132 patients will be enrolled. Enrollment is competitive, with expectation of treating 5 to 10 patients per site in a timeframe of 2 years. The need for a large number of sites is related to the highlight restrictive inclusion and exclusion criteria. The study follow-up after implantation is 1 year.
Eligibility for implant is based on conformance to all prospectively defined inclusion and exclusion criteria. A Patient Review Committee will review all prospective subjects to determine suitability for implant. Subjects who are not deemed suitable for implant will be exited from the study, and classified as late screen failures.
Summary of Results
The CorCinch trial was designed to evaluate the safety and performance of the Accucinch Ventricular Restoration System (AccuCinch) in patients with heart failure with or without functional mitral regurgitation due to dilated or non-ischaemic cardiomyopathy. Implantation of the device to mechanically reduce the size of the left ventricle (main pumping chamber of the heart) and reduce stress on the wall of the ventricle may allow recovery of heart muscle function.
119 patients were enrolled into the trial across the 10 participating hospitals from march 2019 to October 2021. Of these 119 patients, 33 were implanted with the AccuCinch device. Seven patients died after being implanted with the AccuCinch device. None of these deaths were judged to be related to the device or the implant procedure. Twenty-four patients are still being followed up as part of the study, and 9 have exited the study. The study was terminated in European sites by the sponsor for economic and regulatory reasons and continued in North American sites only.
One patient was implanted with the AccuCinch device at Royal Brompton hospital. The patient had initial improvement in his symptoms, but after 24 months his symptoms worsened, culminating in mitral valve replacement surgery, with further surgery 6 months later to correct leakage around the valve. This patient withdrew from the study 4.4 years after receiving his AccuCinch device.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1501
Date of REC Opinion
3 Nov 2017
REC opinion
Further Information Favourable Opinion