The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

NCT ID: NCT02806570

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2024-08-22

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

Conditions

Heart Failure; Mitral Valve Insufficiency; Cardiomyopathies

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

AccuCinch® Ventricular Restoration System

Group Type: EXPERIMENTAL

Mitral valve repair

Intervention Type: DEVICE

Interventions

Mitral valve repair

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ancora Heart, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Zapien, MS, CCRA

Role: STUDY_DIRECTOR

Ancora Heart, Inc. (formerly Guided Delivery Systems Inc.)

Dean Kereiakes, MD

Role: PRINCIPAL_INVESTIGATOR

The Christ Hospital

Satya Shreenivas, MD

Role: PRINCIPAL_INVESTIGATOR

The Christ Hospital

Locations

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

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Carilion Medical Center

Roanoke, Virginia, United States

University of Washington Medicine

Seattle, Washington, United States

Countries

United States

Other Identifiers

4433

Identifier Type: -

Identifier Source: org_study_id