The TRICURE EU Pivotal Study

Not Applicable

Recruiting

• Conditions: Tricuspid Valve Regurgitation; Heart Valve Disease; Cardiovascular Diseases

• 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

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