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The TRICURE First in Human Trial

NCT05126030 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-26

No results posted yet for this study

Summary

The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Conditions

  • Tricuspid Regurgitation

Interventions

DEVICE

Topaz TTVR System

Transcatheter tricuspid heart valve replacement

Sponsors & Collaborators

  • TRiCares

    lead INDUSTRY

Principal Investigators

  • Jean-Louis Vanoverschelde, MD · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  • Emmanuel Teiger, MD · CHU Henri Mondor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2025-03-01
Completion
2029-05-15

Countries

  • Belgium
  • France

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 NCT05126030 on ClinicalTrials.gov