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

NCT00800046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-07-29

No results posted yet for this study

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

Interventions

DEVICE

AccuCinch® Ventriculoplasty System

Mitral valve repair due to functional disease

Sponsors & Collaborators

  • Ancora Heart, Inc.

    lead INDUSTRY

Principal Investigators

  • Joachim Schofer, Prof. Dr. · Medical Care Center Prof. Mathey, Prof. Schofer, GmbH

  • Patrick Perier, MD · Cardiovascular Center Bad Neustadt

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2020-11-30
Completion
2021-01-31
FDA Device
Yes

Countries

  • Austria
  • Germany
  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00800046 on ClinicalTrials.gov