%0 Journal Article
%T TRISCEND II: Novel Randomized Trial Design for Transcatheter Tricuspid Valve Replacement.
%A Grayburn PA
%A Kodali SK
%A Hahn RT
%A Lurz P
%A Thourani VH
%A Kozorovitsky ER
%A Gilmore SY
%A Vinekar C
%A Zhang B
%A Boulware K
%A Krzmarzick AM
%A Nguyen D
%A Vu MT
%A Feldman T
%A Mack MJ
%A Leon MB
%J Am J Cardiol
%V 0
%N 0
%D 2024 Jun 17
%M 38897265
%F 3.133
%R 10.1016/j.amjcard.2024.06.009
%X <B>BACKGROUND: </B>Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR).<BR><B>OBJECTIVE: </B>The TRISCEND II pivotal trial studies the transcatheter EVOQUE tricuspid valve replacement system using an FDA Breakthrough Device Designation - a program intended to provide timely access to medical devices by speeding up development, assessment, and review.<BR><B>METHODS: </B>The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness endpoints for the first 150 patients in the initial phase and a 1-year safety and effectiveness endpoint for the full cohort of 400 patients in the second phase.<BR><B>RESULTS: </B>The TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system.<BR><B>CONCLUSIONS: </B>The design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials.<BR><B>CONCLUSIONS: </B>The TRISCEND II pivotal trial is the first randomized controlled trial of transcatheter tricuspid valve replacement (TTVR). It was designed under the FDA's Breakthrough Device Program to bring a novel TTVR therapy to patients with limited treatment options. A 2-phase design allowed for early review of safety and effectiveness outcomes followed by a full-cohort safety and effectiveness endpoint in the second phase at 1 year. This approach led to approval of the first commercial transcatheter therapy for tricuspid valve replacement.