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2019-06

2019-06 triscend study
Source : Import from center

clinicaltrials.gov reference: NCT04221490
Tricuspid Regurgitation
Transcatheter
Replacement
Functional
Degenerative
Regurgitation
Valve Replacement
Cardiovascular Disease
Source : Import from center
Régurgitation de la valve tricuspide
Maladies de la valve cardiaque
Maladies cardiovasculaires
Recruiment closed
Last modification : 2025/02/18
Study type

Interventional


Target population

Medical condition (targeted specialty)

Therapeutic area choices

Régurgitation de la valve tricuspide

Maladies de la valve cardiaque

Maladies cardiovasculaires

Source : Import from center

Participants profils

Participants gender(s)

ALL

Source : Import from center

Selection criterias

Inclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

* Tricuspid valve anatomic contraindications
* Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months
* Hemodynamic instability
* Refractory heart failure requiring advanced intervention
* Currently participating in another investigational study in which the patient has not reached a primary endpoint

Source : Import from center

Proposed Therapy or Intervention

Cohorts
Name Medical condition Treatment Recruitment status
Treatment Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System Data not available
  • Unknown
  • Treatment
    Recruitment status
    unknown
    Current data since : February 18, 2025 19:00

    Study description

    Study summary

    Prospective, multi-center study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

    Source : Import from center

    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.

    Source : Import from center

    Locations

    Participating centers

      10 shown out of 20 centers
    • INSTITUT UNIVERSITAIRE DE CARDIOLOGIE ET DE PNEUMOLOGIE DE QUÉBEC

      Québec

      QUÉBEC, CANADA

      Local recruitment
      Recruiting status: CLOSED
    • BAYLOR HEART HOPSITAL PLANO

      Plano

      TEXAS, UNITED STATES

      Local recruitment
      Recruiting status: CLOSED
    • BRIGHAM AND WOMEN'S HOSPITAL

      Boston

      MASSACHUSETTS, UNITED STATES

      Local recruitment
      Recruiting status: CLOSED
    • CEDARS-SINAI MEDICAL CENTER

      Los angeles

      CALIFORNIA, UNITED STATES

      Local recruitment
      Recruiting status: CLOSED
    • CHU BORDEAUX, HÔPITAL CARDIOLOGIQUE HAUT LÉVÊQUE

      Pessac

      FRANCE

      Local recruitment
      Recruiting status: CLOSED
    • CLINIQUE PASTEUR

      Toulouse

      BP 27617, FRANCE

      Local recruitment
      Recruiting status: CLOSED
    • COLUMBIA UNIVERSITY IRVING MEDICAL CENTER / NYPH

      New york

      NEW YORK, UNITED STATES

      Local recruitment
      Recruiting status: CLOSED
    • EMORY UNIVERSITY HOSPITAL AND EMORY UNIVERSITY HOSPITAL MIDTOWN

      Atlanta

      GEORGIA, UNITED STATES

      Local recruitment
      Recruiting status: CLOSED
    • HENRY FORD HOSPITAL

      Detroit

      MICHIGAN, UNITED STATES

      Local recruitment
      Recruiting status: CLOSED
    • HOSPITAL OF THE UNIVERSITY OF PENNSYLVANIA/PENN PRESBYTERIAN MEDICAL CENTER

      Philadelphia

      PENNSYLVANIA, UNITED STATES

      Local recruitment
      Recruiting status: CLOSED

    Last modification : February 18, 2025
    Current data since : 21 Feb 06:30
    Data source : clinicaltrials.gov
    clinicaltrials.gov reference: NCT04221490