Cardiomyopathy, Dilated, Heart Failure
Conditions
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.
Interventions
DEVICEAccuCinch® Ventricular Restoration System
AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
Sponsors
Ancora Heart, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by device-related or procedure-related major adverse events (MAEs) | 30-day | Device-related or procedure-related major adverse events (MAEs) |
Countries
United States
Outcome results
None listed