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The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study | Clinical Trials | Clareo Health

COMPLETEDNA

The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Early Feasibility Study of the AccuCinch® Ventricular Restoration System

NCT02806570•Ancora Heart, Inc.

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+6 more criteria

Locations (16)

Emory University

Atlanta, Georgia, United States

University of Louisville

Louisville, Kentucky, United States

Minneapolis Heart Foundation Institute

Minneapolis, Minnesota, United States

Barnes-Jewish Hospital

St Louis, Missouri, United States

Nebraska Heart Institute / Nebraska Heart Hospital

Lincoln, Nebraska, United States

NYU Langone Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, United States

Key Dates

Start Date

August 1, 2016

Primary Completion Date

January 1, 2020

Completion Date

August 22, 2024

Last Updated

January 29, 2025

Enrollment

ACTUAL participants

Conditions

Heart FailureMitral Valve InsufficiencyCardiomyopathies

Interventions

Mitral valve repair

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Inclusion Criteria

Exclusion Criteria

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