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NOT YET RECRUITING
NCT07528326
NA
The TRICURE US IDE Pivotal Study
Sponsor: TRiCares
View on ClinicalTrials.gov
Summary
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.
Official title: TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
831
Start Date
2026-10
Completion Date
2035-09
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
DEVICE
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
DEVICE
Edwards EVOQUE TTVR System
Edwards EVOQUE TTVR System
DEVICE
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System