The TRICURE EU Pivotal Study (TRICURE EU)

The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study

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

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Heart Valve Disease; Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Replacement

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esther Gerteis; Phone Number: +41796015318; Email: gerteis@tricares.de

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Recruiting
    • Algemeen Stedelijk Ziekenhuis
    • Principal Investigator: Liesbeth Rosseel, MD
    • Contact: Liesbeth Rosseel, MD; Phone Number: 003253766730; Email: liesbeth.rosseel@asz.be
  • Antwerp, Belgium
    • Recruiting
    • ZNA Middelheim
    • Contact: Stefan Verheye, MD
  • Brussels, Belgium, 1090
    • Recruiting
    • UZ Brussel
    • Contact: Stijn Lochy, MD
  • Brussels, Belgium
    • Recruiting
    • Cliniques Universitaires Saint-Luc UCL
    • Contact: Joelle Kefer, MD
  • Liège, Belgium
    • Not yet recruiting
    • Centre hospitalier universitaire CHU de Liège
    • Contact: Patrizio Lancellotti, MD
  • Roeselare, Belgium, 8800
    • Recruiting
    • AZ Delta
    • Contact: Maarten Vanhaverbeke, MD
• Germany
  • Mainz, Germany, 55131
    • Not yet recruiting
    • University Medical Center of the Johannes Gutenberg University Mainz
    • Contact: Phiipp Lurz, MD
  • Munich, Germany, 81377
    • Recruiting
    • Ludwig Maximilian University Hospital
    • Contact: Jörg Hausleiter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Tricuspid Valve Replacement; Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement; Replacement of the tricuspid valve through a transcatheter approach; Other Names: TRiCares Topaz Tricuspid Valve Replacement System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: TRiCares
• Investigators: Principal Investigator: Jörg Hausleiter, MD, LMU Munich

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: August 25, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Tricuspid Valve Insufficiency; Heart Valve Diseases
• Other Study ID Numbers: 2401 (Direktion Lehre und Forschung, Inselspital (study number))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No