A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study

Ancora Heart

Status

Completed

Conditions

Mitral Valve Regurgitation

Functional Mitral Regurgitation

Mitral Regurgitation

Treatments

Device: AccuCinch® Ventriculoplasty System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00800046

1436

Details and patient eligibility

About

Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.

Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 18 years
Severity of FMR: ≥ Moderate (i.e., 2+)
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 (specific EuroSCORE (LES or ESII), STS, or comorbidities should demonstrate high risk features)
Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Exclusion criteria

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 (CAD) requiring revasularization
Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
Any planned cardiac surgery within the next 6 months (including right heart procedures)
NYHA class (i.e., non-ambulatory) or ACC/AHA Stage D heart failure
Fixed pulmonary artery systolic pressure >70 mmHg
Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)
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/contraints preventing appropriate access/ implant of the AccuCinch 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
History of stroke within the prior 3 months
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 CRTD) or implantable cardioverter defibrillator within 1 month
Absence of CRT with class I indication criteria for biventricular pacing (left bundle branch block pattern and QRS duration ≥150 ms)
On high dose steroids or immunosuppressant therapy
Female subjects who are pregnant or lactating