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

The TRAVEL II study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve via jugular vein. A series of physical, imaging and laboratory exams will be performed to determine whether a subject has severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation via jugular vein if an informed consent is obtained.

Inclusion criteria

• 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).

Exclusion criteria

• Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
• Subjects with previous transcatheter or surgical tricuspid valve procedure.
• Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
• Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) < 10mm or right ventricle fractional area change (FAC) < 20%).
• Subjects with aortic stenosis (mean ΔP≥ 40mmHg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2) or mitral regurgitation (≥ 3+).
• Subjects with active endocarditis or other infectious diseases.
• Subjects with untreated severe coronary artery disease.
• Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
• Subjects with coagulation disorders.
• Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
• Subjects with cognitive disorders that can not cooperate the study or follow-up.
• Subjects with less than 12 months life expectancy because of non-cardiac conditions.