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.
The TRICURE US IDE Pivotal Study is a prospective, global, multi-center, randomized (1:1) controlled study (RCT) designed to evaluate the safety and effectiveness of the TRiCares Topaz TTVR System compared to the Edwards EVOQUE TTVR System in subjects with severe or greater tricuspid regurgitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
831
TRiCares Topaz TTVR System
Edwards EVOQUE TTVR System
TRiCares Topaz TTVR System
Rate of Major Adverse Events (MAE)
Time frame: 30 days post-procedure
Composite Endpoint
All-cause mortality, heart failure hospitalization, non-elective tricuspid valve reintervention
Time frame: 1 year post-procedure
Change in qualify of life (QoL)
as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline
Time frame: 1 year post-procedure
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