A prospective, multicenter, randomized, controlled pivotal trial to evaluate the safety and effectiveness of transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Medical Center of the Rockies
Protocol Number: 19-6129
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