Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

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

What this study is about