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

Not Applicable

Completed

• Conditions: Mitral Regurgitation; Functional Mitral Regurgitation; Mitral Valve Regurgitation
• Interventions: Device: AccuCinch® Ventriculoplasty System

• Registration Number: NCT00800046
• Lead Sponsor: Ancora Heart, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-11-26
• Study First Posted: 2008-12-01
• Primary Completion: 2020-11
• Study Completion: 2021-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-23
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AccuCinch® Ventriculoplasty System	AccuCinch® Ventriculoplasty System	Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System.

Primary Outcome Measures

Name	Time	Method
Safety through 30 days and reduction in MR acutely and at 30 days.	30 days

Secondary Outcome Measures

Name	Time	Method
Safety and reduction in MR at 1 year.	1 year

Trial Locations

Locations (8)

Vilnius University Hospital Santaros Klinikos; 🇱🇹 Vilnius, Lithuania

Medical Care Center Hamburg University Cardiovascular Center; 🇩🇪 Hamburg, Germany

University Hospital Freiburg-Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Medical University of Vienna; 🇦🇹 Vienna, Austria

St.-Johannes-Hospital; 🇩🇪 Dortmund, Germany

Immanuel Klinikum Bernau Herzzentrum Brandenburg; 🇩🇪 Bernau, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Cardiovascular Center Frankfurt; 🇩🇪 Frankfurt, Germany