A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study

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