Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation

Completed · Not applicable

Conditions studied: Heart Failure, Cardiomyopathy, Dilated

In brief

This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

Key facts

Study ID

NCT03560167

Run by

Ancora Heart, Inc.

People needed

5

Starts

2018-09-24

Expected to finish

2024-01-28

Last updated by the study team

2024-08-16

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 Consortium1; and 2003 ASE Guidelines for grading mitral regurgitation2)
• Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment
• LV Ejection Fraction: ≥20 to ≤40%
• Symptom Status: NYHA II-IV (i.e., ambulatory)
• Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and Angiotensin converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall include CRT and/or ICD when indicated by guidelines.
• Able and willing to complete 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 3 months
• Prior surgical, transcatheter, or percutaneous mitral valve replacement
• 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)
• Fixed pulmonary artery systolic pressure >70 mmHg
• Severe tricuspid regurgitation
• History of stroke within the prior 3 months or any prior stroke with 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 or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair 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
• Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
• Known allergy to nitinol, polyester, or polyethylene
• Any prior true anaphylactic reaction to contrast agents; defined as known anaphylactoid or other non-anaphylactic allergic reactions to contrast agents that cannot be adequately pre-medicated prior to the index procedure.
• Life expectancy < 1 year due to non-cardiac conditions
• Currently participating in another interventional investigational study
• Implant or revision of any rhythm management device (CRT or CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
• Subjects on high dose steroids or immunosuppressant therapy
• Female subjects who are pregnant, of child bearing potential without a documented birth control method, or lactating

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Piedmont Heart — Atlanta, Georgia, United States
• Emory University — Atlanta, Georgia, United States
• University of Louisville — Louisville, Kentucky, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• Minneapolis Heart Foundation Institute — Minneapolis, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Mount Sinai — New York, New York, United States
• The Christ Hospital — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Oklahoma Heart Hospital — Oklahoma City, Oklahoma, United States
• PinnacleHealth Cardiovascular Institute — Harrisburg, Pennsylvania, United States
• Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Austin Heart — Austin, Texas, 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
• Virginia Tech Carilion School of Medicine and Research Institute — Roanoke, Virginia, United States
• University of Washington Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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