NCT00800046CompletedNot Applicable
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ancora Heart, Inc.
- Enrollment
- 16
- Locations
- 8
- Primary Endpoint
- Safety through 30 days and reduction in MR acutely and at 30 days.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
AccuCinch® Ventriculoplasty System
Experimental
Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System.
Intervention: AccuCinch® Ventriculoplasty System (Device)
Outcomes
Primary Outcomes
Safety through 30 days and reduction in MR acutely and at 30 days.
Time Frame: 30 days
Secondary Outcomes
- Safety and reduction in MR at 1 year.(1 year)
Investigators
Study Sites (8)
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