HumRes67784
|
SNCTP000006781
|
BASEC2025-D0106
Study in Humans - TRiCares Topaz Transcatheter System for Tricuspid Valve Replacement in Europe
Summary description of the study
This study is being conducted to investigate the safety and efficacy of the TRiCares Topaz heart valve system for the treatment of patients with severe tricuspid valve regurgitation.
(BASEC)
Intervention under investigation
Implantation of the Topaz transcatheter heart valve system via the vein.
(BASEC)
Disease under investigation
Tricuspid Valve Regurgitation
(BASEC)
Criteria for participation in trial
Patients with severe tricuspid valve regurgitation for whom open-heart surgery would be too risky. (BASEC)
Exclusion criteria
Patients requiring emergency treatment Patients who have recently undergone heart surgery Patients with inflammation of the heart (BASEC)
Patients with severe tricuspid valve regurgitation for whom open-heart surgery would be too risky. (BASEC)
Exclusion criteria
Patients requiring emergency treatment Patients who have recently undergone heart surgery Patients with inflammation of the heart (BASEC)
Trial sites
Bern
(BASEC)
not available
Sponsor
TRiCares GmbH
(BASEC)
Contact
Contact Person Switzerland
Esther Gerteis
+41796015318
gerteis@cluttertricares.deTRiCares GmbH
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
03.02.2026
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
TRICURE EU PIVOTAL Study – TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available