Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06581471

The TRICURE EU Pivotal Study

Led by TRiCares · Updated on 2026-04-15

80

Participants Needed

8

Research Sites

330 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

The TRICURE EU Pivotal Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 8 locations

1

Algemeen Stedelijk Ziekenhuis

Aalst, Belgium, 9300

Actively Recruiting

2

ZNA Middelheim

Antwerp, Belgium

Actively Recruiting

3

UZ Brussel

Brussels, Belgium, 1090

Actively Recruiting

4

Cliniques Universitaires Saint-Luc UCL

Brussels, Belgium

Actively Recruiting

5

Centre hospitalier universitaire CHU de Liège

Liège, Belgium

Not Yet Recruiting

6

AZ Delta

Roeselare, Belgium, 8800

Actively Recruiting

7

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Germany, 55131

Not Yet Recruiting

8

Ludwig Maximilian University Hospital

Munich, Germany, 81377

Actively Recruiting

Loading map...

Research Team

E

Esther Gerteis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

The TRICURE EU Pivotal Study | DecenTrialz