The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Not Applicable

Completed

• Conditions: Heart Failure; Cardiomyopathies; Mitral Valve Insufficiency
• Interventions: Device: Mitral valve repair

• Registration Number: NCT02806570
• Lead Sponsor: Ancora Heart, Inc.

Brief Summary

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

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

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-16
• Study First Posted: 2016-06-20
• Study Start: 2016-08
• Primary Completion: 2020-01
• Study Completion: 2024-08-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AccuCinch® Ventricular Restoration System	Mitral valve repair	-

Primary Outcome Measures

Name	Time	Method
30-Day Safety	30-day	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.

Trial Locations

Locations (16)

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Minneapolis Heart Foundation Institute; 🇺🇸 Minneapolis, Minnesota, United States

Carilion Medical Center; 🇺🇸 Roanoke, Virginia, United States

Penn State Health Milton S. Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

University of Virginia School of Medicine; 🇺🇸 Charlottesville, Virginia, United States

Nebraska Heart Institute / Nebraska Heart Hospital; 🇺🇸 Lincoln, Nebraska, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Washington Medicine; 🇺🇸 Seattle, Washington, United States

NYU Langone Medical Center; 🇺🇸 New York, New York, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Intermountain Medical Center; 🇺🇸 Salt Lake City, Utah, United States

Pinnacle Health Cardiovascular Institute; 🇺🇸 Harrisburg, Pennsylvania, United States

Baylor College of Medicine St. Luke's Medical Center; 🇺🇸 Houston, Texas, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States