Study of LuX-Valve Transcatheter Tricuspid Valve Replacement via Jugular Vein for Severe Tricuspid Regurgitation in Patients at High Surgical Risk

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the LuX-Valve transcatheter tricuspid valve and delivery system via the jugular vein in patients with severe tricuspid regurgitation who are at high risk for surgery. This prospective, multi-center, single-arm trial aims to determine if this device can help symptomatic patients who have limited options due to their surgical risk and valve condition. Participants in the study will undergo implantation of the LuX-Valve system through the jugular vein after being confirmed to have severe tricuspid regurgitation and high surgical risk. The trial involves only one treatment group where all subjects receive this transcatheter valve replacement. The device is designed to replace the tricuspid valve to reduce regurgitation and improve heart function. During the study, participants will have physical exams, imaging tests, and laboratory assessments to confirm eligibility and monitor outcomes. Researchers will track safety and effectiveness through measures including survival and reduction in tricuspid regurgitation at one year. Secondary outcomes include adverse events over up to five years, changes in heart function classification, quality of life assessments, and walking tests. The total duration includes at least one year of follow-up to evaluate these outcomes.

THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein