a study of percutaneous repair of functional mitral regurgitation using the ancora heart, inc. accucinch® ventricular repair system - the cinch-2 study

Conditions: Mitral Regurgitation; Mitral Valve Regurgitation; Functional Mitral Regurgitation

Summary: prospective single-arm study of the accucinch® ventriculoplasty system in the treatment of mitral valve regurgitation through subvalvular mitral repair. purpose: to demonstrate the safety, feasibility and potential efficacy of using the accucinch® ventriculoplasty system to reduce mitral valve regurgitation through subvalvular mitral repair.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * severity of fmr: ≥ moderate (i.e., 2+) * ejection fraction: ≥ 20% to ≤60% * symptom status: nyha ii-iva * 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 euroscore (les or esii), sts, or comorbidities should demonstrate high risk features) * completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule exclusion criteria: * 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 revasularization * hemodynamic instability: hypotension (systolic pressure \<90 mmhg) or requirement for inotropic support or mechanical hemodynamic support * any planned cardiac surgery within the next 6 months (including right heart procedures) * nyha class (i.e., non-ambulatory) or acc/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 * mitral valve area less than 4.0 cm2 * anatomical pathology/contraints preventing appropriate access/ implant of the accucinch 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 * history of stroke within the prior 3 months * 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 crtd) or implantable cardioverter defibrillator within 1 month * absence of crt with class i indication criteria for biventricular pacing (left bundle branch block pattern and qrs duration ≥150 ms) * on high dose steroids or immunosuppressant therapy * female subjects who are pregnant or lactating

Keywords: mitral valve mitral regurgitation functional mitral regurgitation mr fmr heart valve mitral valve insufficiency valve repair valve disorder cardiac surgery