The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Inclusion Criteria: * Study patient is at least 18-years old * Severity of FMR: ≥ Moderate (i.e., 2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10) * Ejection Fraction: ≥20 to ≤60% * Symptom Status: NYHA II-IV (i.e., ambulatory) * Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month * Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team) * Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule Exclusion Criteria: * Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets) * Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days * Prior surgical, transcatheter, or percutaneous mitral valve intervention * Untreated clinically significant coronary artery disease (CAD) requiring revascularization * Hemodynamic instability: Hypotension (systolic pressure \<90 mmHg) or requirement for inotropic support or mechanical hemodynamic support * Any planned …