Status:
RECRUITING
The TRICURE EU Pivotal Study
Lead Sponsor:
TRiCares
Conditions:
Tricuspid Valve Regurgitation
Heart Valve Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06581471
Start Date
August 29 2024
End Date
December 30 2030
Last Update
September 12 2025
Active Locations (8)
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1
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium, 9300
2
ZNA Middelheim
Antwerp, Belgium
3
UZ Brussel
Brussels, Belgium, 1090
4
Cliniques Universitaires Saint-Luc UCL
Brussels, Belgium