Study ID: Triscend II
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
This randomized clinical trial seeks to compare EVOQUE, a system to replace a heart valve, along with optimal medical therapy (OMT) to OMT alone for treatment of patients with severe tricuspid regurgitation (TR).
TR is a condition in which blood flow through the tricuspid valve moves in the incorrect direction during part of the cardiac cycle.
Eligible participants are randomized into two study arms:
- Group 1 undergoes tricuspid valve replacement with the Edwards EVOQUE system and receives OMT from their physicians.
- Group 2 undergoes OMT alone.
Participants then receive follow-up care at discharge, 30 days, three months, six months and annually through five years.
This is a prospective, multicenter, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the Edwards EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe TR.
Primary outcomes being studied include TR grade reduction, reduced major adverse events, and all-cause mortality.
Note: A single-arm registry for patients ineligible for randomization also is available. Contact the clinical trial coordinator for more information.
- Must have symptomatic tricuspid regurgitation (TR) despite medical therapy
- Must have TR graded as severe or greater
- Must be deemed appropriate for transcatheter tricuspid valve replacement per the local heart team
- Other inclusion and exclusion criteria apply