the corcinch - functional mitral valve regurgitation (fmr) study

Conditions: Heart Failure; Mitral Valve Insufficiency; Cardiomyopathies

Summary: this is a multi-center, non-randomized, prospective early feasibility study to evaluate the accucinch® ventricular restoration system in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy

device name changed from accucinch® ventricular repair system to accucinch® ventricular restoration system, fda approval date 08aug2020

Eligibility criteria:
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 cardiac surgery or interventions within the next 6 months (including right heart procedures) * nyha class iv (i.e., non-ambulatory) or american college of cardiology (acc)/american heart association (aha) stage d heart failure * fixed pulmonary artery systolic pressure \>70 mmhg * severe tricuspid regurgitation (per ase guidelines and graded by the echo core lab) * modified rankin scale ≥ 4 disability * hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology. * anatomical pathology/constraints preventing appropriate access/implant of the accucinch® ventricular restoration system (e.g., femoral arteries will not support a 20f system) * renal insufficiency (i.e., egfr of \<30ml/min/1.73m2; stage 4 or 5 ckd) * moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis * fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation * active bacterial endocarditis