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

Study Overview
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Brief Summary
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This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

Detailed Description
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Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.

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

Conditions
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Heart Failure, Cardiomyopathy, Dilated

Intervention / Treatment
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* Device: AccuCinch® Ventricular Restoration System


Participation Criteria
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Eligibility Criteria
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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 Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2) 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-IV (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 Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (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 3 months 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 or interventions within the next 6 months (including right heart procedures) NYHA class IV (i.e., non-ambulatory) Fixed pulmonary artery systolic pressure >70 mmHg Severe tricuspid regurgitation History of 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 Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support a 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

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® Ventricular Restoration System<br> | Device: AccuCinch® Ventricular Restoration System<br>* AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by device-related or procedure-related major adverse events (MAEs) | Device-related or procedure-related major adverse events (MAEs) | 30-day |