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

July 23, 2021 updated by: Ancora Heart, Inc.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • Germany
      • Bad Krozingen, Germany
        • University Hospital Freiburg-Bad Krozingen
      • Bernau, Germany
        • Immanuel Klinikum Bernau Herzzentrum Brandenburg
      • Dortmund, Germany
        • St.-Johannes-Hospital
      • Düsseldorf, Germany
        • Universitätsklinikum Düsseldorf
      • Frankfurt, Germany
        • Cardiovascular Center Frankfurt
      • Hamburg, Germany, 22527
        • Medical Care Center Hamburg University Cardiovascular Center
  • Lithuania
      • Vilnius, Lithuania
        • Vilnius University Hospital Santaros Klinikos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AccuCinch® Ventriculoplasty System
Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System.
Device: AccuCinch® Ventriculoplasty System
Mitral valve repair due to functional disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety through 30 days and reduction in MR acutely and at 30 days.
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and reduction in MR at 1 year.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ancora Heart, Inc.

Investigators

  • Principal Investigator: Joachim Schofer, Prof. Dr., Medical Care Center Prof. Mathey, Prof. Schofer, GmbH
  • Principal Investigator: Patrick Perier, MD, Cardiovascular Center Bad Neustadt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2008

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

November 26, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (Estimate)

December 1, 2008

Study Record Updates

Last Update Posted (Actual)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 23, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1436

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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