Early Feasibility Study of the AccuCinch® Ventricular Restoration System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
- Conditions
- Cardiomyopathy, DilatedHeart Failure
- Interventions
- Device: AccuCinch® Ventricular Restoration System
- Registration Number
- NCT03560167
- Lead Sponsor
- Ancora Heart, Inc.
- Brief Summary
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.
- Detailed Description
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AccuCinch® Ventricular Restoration System AccuCinch® Ventricular Restoration System -
- Primary Outcome Measures
Name Time Method Safety measured by device-related or procedure-related major adverse events (MAEs) 30-day Device-related or procedure-related major adverse events (MAEs)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (19)
Minneapolis Heart Foundation Institute
🇺🇸Minneapolis, Minnesota, United States
Baylor College of Medicine St. Luke's Medical Center
🇺🇸Houston, Texas, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Piedmont Heart
🇺🇸Atlanta, Georgia, United States
Cardiovascular Institute of the South
🇺🇸Houma, Louisiana, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Mount Sinai
🇺🇸New York, New York, United States
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
PinnacleHealth Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, 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
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Oklahoma Heart Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
Austin Heart
🇺🇸Austin, Texas, United States