The TRICURE First in Human Trial

Not Applicable

Active, not recruiting

• Conditions: Tricuspid Regurgitation
• Interventions: Device: Topaz TTVR System

• Registration Number: NCT05126030
• Lead Sponsor: TRiCares

Brief 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.

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 Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-11-18
• Study Start: 2022-07-15
• Status Verified: 2025-03
• Primary Completion: 2025-03-01
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Study Completion: 2029-05-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Primary Cohort	Topaz TTVR System	Device: Topaz TTVR system

Primary Outcome Measures

Name	Time	Method
Hierarchical composite endpoint	30 days	including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days

Trial Locations

Locations (11)

Algemeen Stedelijk Ziekenhuis,; 🇧🇪 Aalst, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

University Hospital Lille, Institut Cœur Poumon; 🇫🇷 Lille, France

Cliniques Universitaires Saint-Luc UCL; 🇧🇪 Bruxelles, Belgium

Centre hospitalier universitaire CHU de Liège; 🇧🇪 Liège, Belgium

CHU Bordeaux; 🇫🇷 Bordeaux, France

Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel; 🇫🇷 Bron Cedex, France

CHU Henri Mondor; 🇫🇷 Créteil, France

Hôpital Saint Joseph; 🇫🇷 Marseille, France

CHU Pontchaillou; 🇫🇷 Rennes, France

Centre Cardiologique du Nord; 🇫🇷 Saint-Denis, France