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
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
This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch®
 Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and
 Recurrent Mitral Regurgitation.
Device name changed from AccuCinch® Ventricular Repair System to AccuCinch® Ventricular
 Restoration System, FDA Approval Date August 14, 2020.
Inclusion Criteria:

 -  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

 Exclusion Criteria:

 -  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