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

Study Overview
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Brief Summary
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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.

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

Conditions
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Mitral Regurgitation, Mitral Valve Regurgitation, Functional Mitral Regurgitation

Intervention / Treatment
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* Device: AccuCinch® Ventriculoplasty System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AccuCinch® Ventriculoplasty System<br>Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System. | Device: AccuCinch® Ventriculoplasty System<br>* Mitral valve repair due to functional disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety through 30 days and reduction in MR acutely and at 30 days. |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and reduction in MR at 1 year. |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mitral valve, Mitral regurgitation, Functional mitral regurgitation, MR, FMR, Heart valve, Mitral valve insufficiency, Valve repair, Valve disorder, Cardiac surgery