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

Tricuspid Regurgitation Clinical Trial

— TRICURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05126030
• Other study ID #: 2101
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: May 15, 2029

Study information

• Verified date: November 2023
• Source: TRiCares GmbH
• Contact: Esther Gerteis
• Phone: +41796015318
• Email: gerteis[@]tricares.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 15, 2029
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Topaz TTVR System
Transcatheter tricuspid heart valve replacement

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis,	Aalst
Belgium	ZNA Middelheim	Antwerpen
Belgium	Cliniques Universitaires Saint-Luc UCL	Bruxelles
Belgium	Centre hospitalier universitaire CHU de Liège	Liège
France	CHU Bordeaux	Bordeaux
France	Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel	Bron Cedex
France	CHU Henri Mondor	Créteil
France	University Hospital Lille, Institut Cœur Poumon	Lille
France	Hôpital Saint Joseph	Marseille
France	CHU Pontchaillou	Rennes
France	Centre Cardiologique du Nord	Saint-Denis

Sponsors (1)

Lead Sponsor	Collaborator
TRiCares GmbH

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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