Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Real World European Investigation of Safety and Clinical Efficacy Using a Novel Device

What this Trial Is About

Researchers are evaluating the Edwards EVOQUE Transcatheter Tricuspid Valve Replacement System in patients with tricuspid valve regurgitation and other heart valve and cardiovascular diseases. This prospective, single-arm, multi-center real-world study aims to gather safety and clinical effectiveness data on this approved device. Up to 500 patients will be enrolled across approximately 45 sites in Europe to better understand patient outcomes with this treatment. Participants will receive treatment with the Edwards EVOQUE system, which replaces the tricuspid valve using a transcatheter approach. The study involves a single treatment group. After the procedure, patients will be followed and assessed at several time points: baseline, during the procedure, at discharge or 7 days post-procedure (whichever comes first), 30 days, 1 year, and then annually for a total of 5 years. Enrollment is expected to last 2 to 4 years. During the study, patients will undergo evaluations of tricuspid regurgitation severity, major adverse events within 30 days, and mortality rates up to 2 years. Additional assessments include heart failure hospitalizations, valve re-interventions, health status questionnaires, and functional class evaluations. Follow-up visits will ensure ongoing monitoring of patient health and treatment outcomes throughout the study duration, which may last up to 9 years including enrollment and follow-up.

Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU)