The TRICURE EFS Study | NCT06506942 | Trialant

The TRICURE EFS Study | NCT06506942 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transcatheter Tricuspid Valve Replacement	Experimental	Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcatheter Tricuspid Valve Replacement	Device	Replacement of the tricuspid valve through a transcatheter approach	Transcatheter Tricuspid Valve Replacement

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite of MAE	Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.	30 day post-intervention
Device Success	Device success defined as a reduction in tricuspid regurgitation immediately post-intervention	immediately post-intervention

Secondary Outcomes

Measure	Description	Time Frame
Six minute walk test	Change in distance (m) compared to baseline assessment	30 days, 6 months, annual for five years post-intervention
Reduction in Tricuspid Regurgitation (TR) Grade	Number of patients presenting with reduction in TR grade compared to baseline assessment

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Susheel Kodali, MD	Columbia University Medical Center/ NewYork Presbyterian Hospital	Principal Investigator
Gorav Ailawadi, MD	University of Michigan Hospital and Health Systems	Principal Investigator

Condition Browse Module