TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial (TRICURE)

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: Recruiting
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Topaz TTVR System

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

• Study Contact: Name: Esther Gerteis; Phone Number: +41796015318; Email: gerteis@tricares.de

Study Locations

• Belgium
  • Aalst, Belgium
    • Recruiting
    • Algemeen Stedelijk Ziekenhuis,
    • Contact: Liesbeth Rosseel, MD
  • Antwerpen, Belgium
    • Recruiting
    • ZNA Middelheim
    • Contact: Stefan Verheye, MD
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires Saint-Luc UCL
    • Contact: Jean-Louis Vanoverschelde, MD
  • Liège, Belgium
    • Recruiting
    • Centre hospitalier universitaire CHU de Liège
    • Contact: Patrizio Lancellotti, MD
• France
  • Bordeaux, France, 33000
    • Not yet recruiting
    • CHU Bordeaux
    • Contact: Julien Ternacle, MD
    • Contact: Thomas Modine, MD
  • Bron Cedex, France, 69677
    • Not yet recruiting
    • Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel
    • Contact: Jean-François Obadia, MD
  • Créteil, France, 94010
    • Recruiting
    • CHU Henri Mondor
    • Contact: Emmanuel Teiger, MD
    • Contact: Romain Gallet, MD
  • Lille, France, 59037
    • Not yet recruiting
    • University Hospital Lille, Institut Cœur Poumon
    • Contact: Eric van Belle, MD
  • Marseille, France, 13008
    • Recruiting
    • Hôpital Saint Joseph
    • Contact: Leopold Oliver, MD
    • Contact: Alexandre Metras, MD
  • Rennes, France, 35000
    • Not yet recruiting
    • CHU Pontchaillou
    • Contact: Guillaume Leurent, MD
    • Contact: Erwan Donal, MD
  • Saint-Denis, France, 93200
    • Recruiting
    • Centre Cardiologique du Nord
    • Contact: Julien Dreyfus, MD
    • Contact: Mohammed Nejjari, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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

• Sponsor: TRiCares GmbH
• Investigators: Principal Investigator: Jean-Louis Vanoverschelde, MD, Cliniques Universitaires Saint-Luc; Principal Investigator: Emmanuel Teiger, MD, CHU Henri Mondor

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): April 15, 2024
• 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): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency
• 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