The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

NCT02806570 | Completed FDA Device

• 1 other identifier: 4433
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 16

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

Conditions

Heart Failure; Mitral Valve Insufficiency; Cardiomyopathies

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

AccuCinch® Ventricular Restoration System

EXPERIMENTAL

Device: Mitral valve repair

Interventions

Mitral valve repair DEVICE

AccuCinch® Ventricular Restoration System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

Study Sites (16)

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Minneapolis Heart Foundation Institute

Minneapolis, Minnesota, 55407, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Nebraska Heart Institute / Nebraska Heart Hospital

Lincoln, Nebraska, 68526, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The Christ Hospital

Cincinnati, Ohio, United States

Location

Pinnacle Health Cardiovascular Institute

Harrisburg, Pennsylvania, 17101, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Baylor College of Medicine St. Luke's Medical Center

Houston, Texas, 77020, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84109, United States

Location

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Location

Carilion Medical Center

Roanoke, Virginia, 24014, United States

Location

University of Washington Medicine

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Heart Failure; Mitral Valve Insufficiency; Cardiomyopathies

Interventions

Mitral Valve Annuloplasty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases

Intervention Hierarchy (Ancestors)

Cardiac Valve Annuloplasty; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• Michael Zapien, MS, CCRA

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

  STUDY DIRECTOR

• Dean Kereiakes, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

• Satya Shreenivas, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: June 20, 2016
• Study Start: August 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: August 22, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

US (16)