NCT06581471

Brief Summary

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
56mo left

Started Aug 2024

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
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 Progress27%
Aug 2024Dec 2030

First Submitted

Initial submission to the registry

August 25, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

August 29, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2030

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

August 25, 2024

Last Update Submit

April 10, 2026

Conditions

Tricuspid Valve RegurgitationHeart Valve DiseaseCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • Composite of MAE

    Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.

    30 day post-intervention

  • Investigational Device Success

    Device success defined as a reduction in tricuspid regurgitation immediately post-intervention

    immediately post-intervention

Secondary Outcomes (3)

  • Six minute walk test

    30 days, 6 months, annual for five years post-intervention

  • Reduction in Tricuspid Regurgitation (TR) Grade

    30 days, 6 months, annual for five years post-intervention

  • New York Heart Association (NYHA) Function Class

    30 days, 6 months, annual for five years post-intervention

Study Arms (1)

Transcatheter Tricuspid Valve Replacement

EXPERIMENTAL

Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Device: Transcatheter Tricuspid Valve Replacement

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

Replacement of the tricuspid valve through a transcatheter approach

Also known as: TRiCares Topaz Tricuspid Valve Replacement System
Transcatheter Tricuspid Valve Replacement

Eligibility Criteria

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

You may qualify if:

  • Adult patients
  • Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
  • Institutional Heart Team evaluates patient as being at increased operative risk

You may not qualify if:

  • Patient in need of emergent intervention
  • Patient who is hemodynamically unstable
  • Anatomical contraindications for implantation with study device
  • Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Algemeen Stedelijk Ziekenhuis

Aalst, 9300, Belgium

RECRUITING

ZNA Middelheim

Antwerp, Belgium

RECRUITING

UZ Brussel

Brussels, 1090, Belgium

RECRUITING

Cliniques Universitaires Saint-Luc UCL

Brussels, Belgium

RECRUITING

Centre hospitalier universitaire CHU de Liège

Liège, Belgium

NOT YET RECRUITING

AZ Delta

Roeselare, 8800, Belgium

RECRUITING

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, 55131, Germany

NOT YET RECRUITING

Ludwig Maximilian University Hospital

Munich, 81377, Germany

RECRUITING

MeSH Terms

Conditions

Tricuspid Valve InsufficiencyHeart Valve DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

  • Jörg Hausleiter, MD

    LMU Munich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Esther Gerteis

CONTACT

+41796015318gerteis@tricares.de

Study Design

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

Study Record Dates

First Submitted

August 25, 2024

First Posted

September 3, 2024

Study Start

August 29, 2024

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

December 30, 2030

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BE(6)DE(2)