The TRICURE EU Pivotal Study

Last updated: September 5, 2025
Sponsor: TRiCares
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vascular Diseases

Heart Valve Disease

Treatment

Transcatheter Tricuspid Valve Replacement

Clinical Study ID

NCT06581471
2401
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients

  • Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)

  • Institutional Heart Team evaluates patient as being at increased operative risk

Exclusion

Exclusion Criteria:

  • Patient in need of emergent intervention

  • Patient who is hemodynamically unstable

  • Anatomical contraindications for implantation with study device

  • Patient who is currently participating in another clinical investigation where theprimary endpoint was not reached yet

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: Transcatheter Tricuspid Valve Replacement
Phase:
Study Start date:
August 29, 2024
Estimated Completion Date:
December 30, 2030

Study Description

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

Connect with a study center

  • Algemeen Stedelijk Ziekenhuis

    Aalst, 9300
    Belgium

    Site Not Available

  • Algemeen Stedelijk Ziekenhuis

    Aalst 2803448, 9300
    Belgium

    Active - Recruiting

  • ZNA Middelheim

    Antwerp 2803138,
    Belgium

    Active - Recruiting

  • ZNA Middelheim

    Antwerpen,
    Belgium

    Site Not Available

  • Cliniques Universitaires Saint-Luc UCL

    Brussels 2800866,
    Belgium

    Active - Recruiting

  • UZ Brussel

    Brussels 2800866, 1090
    Belgium

    Active - Recruiting

  • Cliniques Universitaires Saint-Luc UCL

    Bruxelles,
    Belgium

    Site Not Available

  • UZ Brussel

    Bruxelles, 1090
    Belgium

    Site Not Available

  • Centre hospitalier universitaire CHU de Liège

    Liège,
    Belgium

    Site Not Available

  • Centre hospitalier universitaire CHU de Liège

    Liège 2792413,
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare, 8800
    Belgium

    Site Not Available

  • AZ Delta

    Roeselare 2787889, 8800
    Belgium

    Active - Recruiting

  • University Medical Center of the Johannes Gutenberg University Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • University Medical Center of the Johannes Gutenberg University Mainz

    Mainz 2874225, 55131
    Germany

    Site Not Available

  • Ludwig Maximilian University Hospital

    Munich, 81377
    Germany

    Site Not Available

  • Ludwig Maximilian University Hospital

    Munich 2867714, 81377
    Germany

    Active - Recruiting

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