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

Ancora Heart

Status

Completed

Conditions

Cardiomyopathy, Dilated

Heart Failure

Treatments

Device: AccuCinch® Ventricular Restoration System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03560167

5018

Details and patient eligibility

About

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.

Full description

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

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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