Status:
COMPLETED
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
Lead Sponsor:
Ancora Heart, Inc.
Conditions:
Mitral Regurgitation
Mitral Valve Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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, feasibilit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00800046
Start Date
November 1 2008
End Date
January 1 2021
Last Update
July 29 2021
Active Locations (8)
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1
Medical University of Vienna
Vienna, Austria
2
University Hospital Freiburg-Bad Krozingen
Bad Krozingen, Germany
3
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau, Germany
4
St.-Johannes-Hospital
Dortmund, Germany