2019-06 TRISCEND Study

  • STATUS
    Recruiting
  • End date
    Dec 28, 2025
  • participants needed
    15
  • sponsor
    Edwards Lifesciences
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Updated on 19 February 2024
See if I qualify
medical therapy
tricuspid valve replacement

Summary

Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Description

The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Details
Condition Tricuspid Regurgitation, Heart disease, Heart disease, VALVULAR HEART DISEASE, Cardiovascular Disease
Age 18years - 100years
Treatment Transcatheter Tricuspid Valve Replacement
Clinical Study IdentifierNCT04221490
SponsorEdwards Lifesciences
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Functional or degenerative TR moderate or greater
Symptomatic despite medical therapy
The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement

Exclusion Criteria

Unsuitable anatomy
Previous tricuspid valve repair or replacement
Comorbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow- up requirements, or that could impact the scientific integrity of the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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