THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.
• Age ≥ 50 years at time of consent.
• Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.
• The site heart team confirmed the subject is at high risk for tricuspid valve surgery (euroSCORE II ≥ 7.0%) and the subject will get benefit from the intervention.
• Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
• Subjects are with New York Heart Association (NYHA) Functional Class III or IV.
• Subjects are with normal left heart function (EF ≥ 50%).
• No indications for left-sided or pulmonary valve intervention.
• Subjects must have severe or greater tricuspid regurgitation ( the vena contracta (VC) width ≥ 7 mm or the effective regurgitant orifice area (EROA) ≥ 40 mm2), which confirmed by the Echocardiography Core Lab (ECL) via transthoracic echocardiogram (TTE).