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

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 Consortium11; and 2003 ASE Guidelines for grading
mitral regurgitation10)

- 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-IVa (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 ACEi or 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 30 days

- 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 within the next 6 months (including right heart
procedures)

- NYHA class IVb (i.e., non-ambulatory) or ACC/AHA Stage D heart failure

- Fixed pulmonary artery systolic pressure >70 mmHg

- Severe tricuspid regurgitation

- History of any 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

- Mitral valve area less than 4.0 cm2

- Anatomical pathology/constraints preventing appropriate access/implant of the
AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support an 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