The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
Algemeen Stedelijk Ziekenhuis
RECRUITING
Aalst
ZNA Middelheim
RECRUITING
Antwerp
Cliniques Universitaires Saint-Luc UCL
RECRUITING
Brussels
UZ Brussel
RECRUITING
Brussels
Centre hospitalier universitaire CHU de Liège
NOT_YET_RECRUITING
Liège
AZ Delta
RECRUITING
Roeselare
Germany
University Medical Center of the Johannes Gutenberg University Mainz
NOT_YET_RECRUITING
Mainz
Ludwig Maximilian University Hospital
RECRUITING
Munich
Contact Information
Primary
Esther Gerteis
gerteis@tricares.de
+41796015318
Time Frame
Start Date: 2024-08-29
Estimated Completion Date: 2030-12-30
Participants
Target number of participants: 80
Treatments
Experimental: Transcatheter Tricuspid Valve Replacement
Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System
Related Therapeutic Areas
Sponsors
Leads: TRiCares