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

Recruiting now · Not applicable

Conditions studied: Tricuspid Valve Regurgitation

In brief

The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

Key facts

Study ID

NCT05194423

Run by

Changhai Hospital

People needed

150

Starts

2022-03-01

Expected to finish

2027-03-01

Last updated by the study team

2022-01-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Changhai Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Shanghai Zhongshan Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China
• Wuhan Union Hospital — Wuhan, Hubei, China
• Xijing Hospital — Xi'an, Shaanxi, China
• West China Hospital — Chengdu, Sichuan, China
• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Fu Wai Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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