Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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