The CorCinch - Functional Mitral Valve Regurgitation (FMR) Study

Completed · Not applicable

Conditions studied: Heart Failure, Mitral Valve Insufficiency, Cardiomyopathies

In brief

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

Key facts

Study ID

NCT02806570

Run by

Ancora Heart, Inc.

People needed

35

Starts

2016-08-01

Expected to finish

2024-08-22

Last updated by the study team

2025-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Active bacterial endocarditis

Where it is running

• 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

Full record on ClinicalTrials.gov

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