The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Study Overview
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Brief Summary
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This is a multi-center, non-randomized, prospective Early Feasibility Study to evaluate the AccuCinch® Ventricular Restoration System in patients with symptomatic heart failure and concomitant functional mitral regurgitation that have stable symptoms on guideline-directed medical therapy

Detailed Description
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Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date 08Aug2020

Official Title
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Early Feasibility Study of the AccuCinch® Ventricular Restoration System

Conditions
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Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies

Intervention / Treatment
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* Device: Mitral valve repair


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 Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10) Ejection Fraction: ≥20 to ≤60% Symptom Status: NYHA II-IV (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 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) 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 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. Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch® Ventricular Restoration 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

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: Mitral valve repair<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day Safety | Assess 30-day safety defined as device-related or procedure-related major adverse events (MAEs). MAE is a composite of death; myocardial infarction; emergent conversion to surgery; stroke; major cardiac structure complication; major vascular complication; and heart failure-related hospitalization. | 30-day |