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Clinical Trial Summary

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system


Clinical Trial Description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04482062
Study type Interventional
Source Edwards Lifesciences
Contact TMTT Clinical
Phone 949-250-2500 or 800-424-3278
Email TMTT_Clinical@Edwards.com
Status Recruiting
Phase N/A
Start date April 9, 2021
Completion date December 31, 2029

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