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

NCT00800046 | Completed FDA Device

• 1 other identifier: 1436
• Study Type: interventional
• Target: 16
• Locations: 3 countries
• Sites: 8

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.

Conditions

Mitral Regurgitation; Mitral Valve Regurgitation; Functional Mitral Regurgitation

Keywords

Mitral valve; Mitral regurgitation; Functional mitral regurgitation; MR; FMR; Heart valve; Mitral valve insufficiency; Valve repair; Valve disorder; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• Safety through 30 days and reduction in MR acutely and at 30 days.

  30 days

Secondary Outcomes (1)

• Safety and reduction in MR at 1 year.

  1 year

Study Arms (1)

AccuCinch® Ventriculoplasty System

EXPERIMENTAL

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

Device: AccuCinch® Ventriculoplasty System

Interventions

AccuCinch® Ventriculoplasty System DEVICE

Mitral valve repair due to functional disease

AccuCinch® Ventriculoplasty System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ancora Heart, Inc.: lead

Study Sites (8)

Medical University of Vienna

Vienna, Austria

Location

University Hospital Freiburg-Bad Krozingen

Bad Krozingen, Germany

Location

Immanuel Klinikum Bernau Herzzentrum Brandenburg

Bernau, Germany

Location

St.-Johannes-Hospital

Dortmund, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Cardiovascular Center Frankfurt

Frankfurt, Germany

Location

Medical Care Center Hamburg University Cardiovascular Center

Hamburg, 22527, Germany

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Joachim Schofer, Prof. Dr.

  Medical Care Center Prof. Mathey, Prof. Schofer, GmbH

  PRINCIPAL INVESTIGATOR

• Patrick Perier, MD

  Cardiovascular Center Bad Neustadt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2020
• Study Completion: January 1, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

DE (6); LI (1); AU (1)