The TRICURE First in Human Trial (TRICURE)

March 21, 2025 updated by: TRiCares

TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • Algemeen Stedelijk Ziekenhuis,
      • Antwerpen, Belgium
        • ZNA Middelheim
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc UCL
      • Liège, Belgium
        • Centre hospitalier universitaire CHU de Liège
  • France
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Bron Cedex, France, 69677
        • Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel
      • Créteil, France, 94010
        • CHU Henri Mondor
      • Lille, France, 59037
        • University Hospital Lille, Institut Cœur Poumon
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Rennes, France, 35000
        • CHU Pontchaillou
      • Saint-Denis, France, 93200
        • Centre Cardiologique du Nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject of age >18 years.

  • Subject with severe symptomatic tricuspid regurgitation presenting following conditions:

    1. TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
    2. symptoms requiring use of diuretics.
  • Subject presenting with New York Heart Association Class NYHA ≥II.
  • Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.

Exclusion Criteria:

  • Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months.
  • Subject undergoing cardiac interventions within 30 days prior to index procedure.
  • Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis.
  • Subject who had previous tricuspid valve replacement or repair and a device is still in situ.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Primary Cohort
Device: Topaz TTVR system
Device: Topaz TTVR System
Transcatheter tricuspid heart valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hierarchical composite endpoint
Time Frame: 30 days
including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TRiCares

Investigators

  • Principal Investigator: Jean-Louis Vanoverschelde, MD, Cliniques Universitaires Saint-Luc
  • Principal Investigator: Emmanuel Teiger, MD, CHU Henri Mondor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Actual)

March 1, 2025

Study Completion (Estimated)

May 15, 2029

Study Registration Dates

First Submitted

October 28, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2101 (Other Identifier: BCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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