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
Ancora Heart, Inc.
Duration of Study in the UK
3 years, 0 months, 1 days
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.
London - Dulwich Research Ethics Committee
Date of REC Opinion
3 Nov 2017
Further Information Favourable Opinion