The TRICURE US IDE Pivotal Study
ConditionTricuspid Regurgitation (TR)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTRiCares
About this trial
The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.
Eligibility criteria
Qualifiers
Patient is ≥ 18 years of age
Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy
Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team
Disqualifiers
Patient has a tricuspid device currently in place
Patient has anatomical contraindications
Patient is in need of urgent surgery
Patient has a left ventricular ejection fraction of < 25%
Trial design
Treatments tested in this trial
- TRiCares Topaz TTVR System
- Edwards EVOQUE TTVR System
- TRiCares Topaz TTVR System
Treatment groups
831 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov