Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy using a Novel Device Short Title: TRISCEND II Pivotal Trial

Brief description of study

The objectives of this clinical study are to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system with OMT compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation (TR).a

Clinical Study Identifier: s20-01862

ClinicalTrials.gov Identifier: NCT04482062

Principal Investigator: Mathew R. Williams.

Other Investigators: Tara Ann Collins, Alan F Vainrib, Muhamed Saric, Daniel G Bamira, Alex Reyentovich, Cezar S Staniloae, Bernard Shown Kadosh.

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