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EASE TRICUSPID Expertise-based Assessment Study on Clinical Efficacy of Contour 3D® in TRICUSPID Valve Annuloplasty

NCT01532921 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 85

Last updated 2018-08-10

Study results available
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Summary

Few clinical evidence for the Contour 3D Tricuspid Annuloplasty Ring exists; therefore, in order to position this product on the market, a post-market release study was completed. The purpose of this study was to evaluate the hemodynamic performance of the Contour 3D® Tricuspid Annuloplasty Ring following Tricuspid Valve (TV) repair in a post-market environment.

Conditions

  • Tricuspid Valve Insufficiency

Interventions

PROCEDURE

Tricuspid valve repair

PROCEDURE

Left-sided heart surgery

Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned

DEVICE

Contour 3D Tricuspid Annuloplasty Ring

Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Rüdiger Lange, Prof. Dr. · Deutsches Herzzentrum München

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • France
  • Germany
  • Israel

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 NCT01532921 on ClinicalTrials.gov