Functional Mitral Regurgitation, Mitral Regurgitation, Mitral Valve Regurgitation
Conditions
Keywords
Mitral valve, Mitral regurgitation, Functional mitral regurgitation, MR, FMR, Heart valve, Mitral valve insufficiency, Valve repair, Valve disorder, Cardiac surgery
Brief summary
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.
Interventions
Mitral valve repair due to functional disease
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety through 30 days and reduction in MR acutely and at 30 days. | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety and reduction in MR at 1 year. | 1 year |
Countries
Austria, Germany, Lithuania
Outcome results
None listed