Clinical Trial of the Week: Device study for patients who need tricuspid valve replacement

By Donna Loyle, communications manager, LIMR

 

Triscend II is a multicenter randomized clinical trial that is comparing 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).

 

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.

 

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.

 

William Gray is the MLH principal investigator for this study approved for Lankenau Medical Center. For more, visit https://www.mainlinehealth.org/research/clinical-trials/triscend-ii

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