for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around



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.

Official Title

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


Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular Restoration System, FDA Approval Date August 14, 2020.


Heart Failure, Cardiomyopathy, Dilated, Cardiomyopathies, Mitral Valve Insufficiency, Dilated Cardiomyopathy, AccuCinch® Ventricular Restoration System


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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


  • UCSF
    San Francisco California 94143 United States
  • Intermountain Medical Center
    Salt Lake City Utah 84109 United States


in progress, not accepting new patients
Start Date
Completion Date
Ancora Heart, Inc.
Study Type
About 5 people participating
Last Updated