NCT05126030

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.

Trial Health

78
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
37mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

11 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jul 2022May 2029

First Submitted

Initial submission to the registry

October 28, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2029

Expected
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

October 28, 2021

Last Update Submit

March 21, 2025

Conditions

Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Primary Cohort

EXPERIMENTAL

Device: Topaz TTVR system

Device: Topaz TTVR System

Interventions

Topaz TTVR SystemDEVICE

Transcatheter tricuspid heart valve replacement

Primary Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Algemeen Stedelijk Ziekenhuis,

Aalst, Belgium

Location

ZNA Middelheim

Antwerp, Belgium

Location

Cliniques Universitaires Saint-Luc UCL

Brussels, 1200, Belgium

Location

Centre hospitalier universitaire CHU de Liège

Liège, Belgium

Location

CHU Bordeaux

Bordeaux, 33000, France

Location

Hospices Civils de Lyon, Hôpital Cardiothoracique Louis Pradel

Bron, 69677, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

University Hospital Lille, Institut Cœur Poumon

Lille, 59037, France

Location

Hôpital Saint Joseph

Marseille, 13008, France

Location

CHU Pontchaillou

Rennes, 35000, France

Location

Centre Cardiologique du Nord

Saint-Denis, 93200, France

Location

Related Publications (1)

  • Teiger E, Nejjari M, Rosseel L, Kefer J, Verheye S, Lancellotti P, Oliver L, Obadia JF, Asch FM, Blanke P, Dreyfus J. TRICURE: first-in-human study of the Topaz transcatheter tricuspid heart valve system. EuroIntervention. 2025 Nov 14;21(22):1377-1385. doi: 10.4244/EIJ-D-25-00423.

    PMID: 41243777DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Jean-Louis Vanoverschelde, MD

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

  • Emmanuel Teiger, MD

    CHU Henri Mondor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Topaz TTVR System
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 18, 2021

Study Start

July 15, 2022

Primary Completion

March 1, 2025

Study Completion (Estimated)

May 15, 2029

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(4)FR(7)