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NCT Number: NCT06581471

The TRICURE EU Pivotal Study

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

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Key information

Conditions

Tricuspid Valve Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Disease Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Algemeen Stedelijk Ziekenhuis, Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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 the primary endpoint was not reached yet

Treatment and study plan

Transcatheter Tricuspid Valve Replacement

Device

Replacement of the tricuspid valve through a transcatheter approach

Other names: TRiCares Topaz Tricuspid Valve Replacement System

Primary outcomes

  1. Composite of MAE

    Time frame: 30 day post-intervention

    Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.

  2. Investigational Device Success

    Time frame: immediately post-intervention

    Device success defined as a reduction in tricuspid regurgitation immediately post-intervention

Secondary outcomes

  1. Six minute walk test

    Time frame: 30 days, 6 months, annual for five years post-intervention

    Change in distance (m) compared to baseline assessment

  2. Reduction in Tricuspid Regurgitation (TR) Grade

    Time frame: 30 days, 6 months, annual for five years post-intervention

    Number of patients presenting with reduction in TR grade compared to baseline assessment

  3. New York Heart Association (NYHA) Function Class

    Time frame: 30 days, 6 months, annual for five years post-intervention

    Number of patients presenting with improvement in NYHA classification

Study contacts

Contact information is provided by the study sponsor or research team.

Esther Gerteis

CONTACT

[email protected]

+41796015318

Sponsors and collaborators

Lead sponsor

TRiCares

Industry

Registry information

Official study title

The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study

Acronym: TRICURE EU

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Sep 3, 2024
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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