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Active, Not Recruiting

NCT Number: NCT05126030

The TRICURE 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Algemeen Stedelijk Ziekenhuis,, Aalst, Belgium

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject of age >18 years.
  • Subject with severe symptomatic tricuspid regurgitation presenting following conditions:
  • TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or
  • 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.

Treatment and study plan

Topaz TTVR System

Device

Transcatheter tricuspid heart valve replacement

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

TRiCares

Industry

Registry information

Official study title

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

Acronym: TRICURE

Important dates

Study start
2022
Primary completion
2025
Study completion
2029
First posted
Nov 18, 2021
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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