early feasibility study of the accucinch® ventricular restoration system in patients with prior mitral valve intervention (pmvi) and recurrent mitral regurgitation

Conditions: Heart Failure; Cardiomyopathy, Dilated

Summary: this is a non-randomized, prospective, multi-center early feasibility study of the accucinch® ventricular restoration system in patients with prior mitral valve intervention (pmvi) and recurrent mitral regurgitation.

device name changed from accucinch® ventricular repair system to accucinch® ventricular restoration system, fda approval date august 14, 2020.

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 consortium1; and 2003 ase guidelines for grading mitral regurgitation2) * patient has had a prior surgical or percutaneous mitral repair procedure \>3 months prior to enrollment * lv ejection fraction: ≥20 to ≤40% * symptom status: nyha ii-iv (i.e., ambulatory) * prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and angiotensin converting enzyme inhibitor (acei) or angiotensin ii receptor blockers (arb) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). treatment shall include crt and/or icd when indicated by guidelines. * able and willing to complete 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 3 months * prior surgical, transcatheter, or percutaneous mitral valve replacement * 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) * fixed pulmonary artery systolic pressure \>70 mmhg * severe tricuspid regurgitation * history of stroke within the prior 3 months or any prior stroke with 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 or constraints preventing appropriate access/implant of the accucinch® ventricular repair 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 * subjects in whom anticoagulation or antiplatelet therapy is contraindicated * known allergy to nitinol, polyester, or polyethylene * any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure. * life expectancy \< 1 year due to non-cardiac conditions * currently participating in another interventional investigational study * implant or revision of any rhythm management device (crt or crt-d) prior 3 months or implantable cardioverter defibrillator within the prior 1 month * subjects on high dose steroids or immunosuppressant therapy * female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating