Safety and Performance of the AccuCinch® System

Ancora Heart

Status

Withdrawn

Conditions

Mitral Valve Insufficiency

Heart Failure

Treatments

Device: Accucinch Implant

Study type

Interventional

Funder types

Industry

Identifiers

NCT02624960

4432

Details and patient eligibility

About

This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Study patient is an adult of legal consent age
Severity of FMR: ≥ Moderate
Ejection Fraction: ≥20 to ≤60%
Symptom Status: NYHA II-IVa
Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
Surgical risk: Subject is eligible for cardiac surgery

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 30 days
Prior surgical, transcatheter, or percutaneous mitral valve intervention
Untreated clinically significant coronary artery disease requiring revascularization
Hemodynamic instability: Hypotension or requirement for inotropic support or mechanical hemodynamic support
Any planned cardiac surgery or interventions within the next 6 months
NYHA class IVb (i.e., non-ambulatory) or ACC/AHA Stage D heart failure
Fixed pulmonary artery systolic pressure >70 mmHg
Severe tricuspid regurgitation
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
Mitral valve area less than 4.0 cm2
Anatomical pathology/constraints preventing appropriate access/implant of the GDS Accucinch System
Renal insufficiency
Mitral annular calcification
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
History of stroke within the prior 3 months
Subjects in whom anticoagulation is contraindicated
Anemia
Thrombocytopenia or thrombocytosis
Bleeding disorders or hypercoaguable state
Active peptic ulcer or active gastrointestinal bleeding
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 or implantable cardioverter defibrillator within the prior month
Absence of CRT with class I indication criteria for biventricular pacing - Subjects on high dose steroids or immunosuppressant therapy
Female subjects who are pregnant, of child bearing potential or lactating