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

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