The TRICURE US IDE Pivotal Study

TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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%
• Patient has life expectancy of < 1 year