The TRICURE EU Pivotal Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTRiCares
About this trial
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcatheter Tricuspid Valve Replacement
Treatment groups
80 Participants
are divided into 1 treatment groupLocations
8Belgium
Algemeen Stedelijk Ziekenhuis9300, Aalst Belgium
ZNA Middelheim Antwerp Belgium
Cliniques Universitaires Saint-Luc UCL Brussels Belgium
UZ Brussel1090, Brussels Belgium
Sponsors and collaborators
TRiCares
Lead sponsor
Source ClinicalTrials.gov