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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
2026-07-08
Completion Date
2035-09
Last Updated
2026-10-22
Healthy Volunteers
No
Conditions
Interventions
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
Edwards EVOQUE TTVR System
Edwards EVOQUE TTVR System
TRiCares Topaz TTVR System
TRiCares Topaz TTVR System
Locations (1)
Piedmont Heart Institute
Atlanta, Georgia, United States