Early Feasibility Study of the AccuCinch® Ventricular Repair System - The CorCinch-FMR Study

Inclusion Criteria:

- Study patient is an adult of legal consent age.

- Severity of functional mitral regurgitation (FMR): ≥ Moderate (i.e., 2+, according to
2003 ASE Guidelines for grading mitral regurgitation)

- Ejection Fraction: ≥20 to ≤60%

- Symptom Status: New York Heart Association (NYHA) II-IVa (i.e., ambulatory)

- 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 risk score or
comorbidities should demonstrate high risk features, as determined by the Heart Team)

- Completion of 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 intervention

- Untreated clinically significant coronary artery disease (CAD) requiring
revascularization

- Hemodynamic instability: Hypotension (systolic pressure <90 millimeter Mercury (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 IVb (i.e., non-ambulatory) or American College of Cardiology (ACC)/American
Heart Association (AHA) Stage D heart failure

- Fixed pulmonary artery systolic pressure >70 mmHg

- Severe tricuspid regurgitation (per American Society of Echocardiography (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 centimeter2 (cm2)

- Anatomical pathology/constraints preventing appropriate access/implant of the GDS
AccuCinch System (e.g., femoral arteries will not support an 18 French (Fr) system)

- Renal insufficiency (i.e., estimated glomerular filtration rate (eGFR) of <30
milliliters/minute/meter (ml/min/1.73m2); Stage 4 or 5 chronic kidney disease (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 anti-platelet 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 (cardiac resynchronization therapy
(CRT) or cardiac resynchronization therapy device (CRT-D)) or implantable cardioverter
defibrillator within the prior month

- Absence of CRT with class I indication criteria for biventricular pacing (left bundle
branch block pattern and Q-wave/R-wave/S-wave (QRS) duration ≥150 milliseconds (ms))

- 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