The TRICURE EU Pivotal Study

Not Applicable

Recruiting

• Conditions: Tricuspid Valve Regurgitation; Heart Valve Disease; Cardiovascular Diseases
• Interventions: Device: Transcatheter Tricuspid Valve Replacement

• Registration Number: NCT06581471
• Lead Sponsor: TRiCares

Brief Summary

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

Detailed Description

The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.

Study Timeline

• Study First Submitted: 2024-08-25
• Study First Submitted QC: 2024-08-26
• Study Start: 2024-08-29
• Study First Posted: 2024-09-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2025-12-30
• Study Completion: 2030-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcatheter Tricuspid Valve Replacement	Transcatheter Tricuspid Valve Replacement	Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Primary Outcome Measures

Name	Time	Method
Composite of MAE	30 day post-intervention	Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Investigational Device Success	immediately post-intervention	Device success defined as a reduction in tricuspid regurgitation immediately post-intervention

Secondary Outcome Measures

Name	Time	Method
Six minute walk test	30 days, 6 months, annual for five years post-intervention	Change in distance (m) compared to baseline assessment
Reduction in Tricuspid Regurgitation (TR) Grade	30 days, 6 months, annual for five years post-intervention	Number of patients presenting with reduction in TR grade compared to baseline assessment
New York Heart Association (NYHA) Function Class	30 days, 6 months, annual for five years post-intervention	Number of patients presenting with improvement in NYHA classification

Trial Locations

Locations (8)

Algemeen Stedelijk Ziekenhuis; 🇧🇪 Aalst, Belgium

ZNA Middelheim; 🇧🇪 Antwerpen, Belgium

UZ Brussel; 🇧🇪 Bruxelles, Belgium

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

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

AZ Delta; 🇧🇪 Roeselare, Belgium

University Medical Center of the Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Germany

Ludwig Maximilian University Hospital; 🇩🇪 Munich, Germany