THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve

  • STATUS
    Recruiting
  • End date
    Jun 5, 2026
  • participants needed
    150
  • sponsor
    Changhai Hospital
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Updated on 19 February 2024
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regurgitation
transthoracic echocardiogram
tricuspid valve replacement

Summary

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.

Description

The TRAVEL study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve. 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 if an informed consent is obtained.

Details
Condition Tricuspid Regurgitation, VALVULAR HEART DISEASE
Age 50years - 100years
Treatment Tricuspid Valve Replacement System
Clinical Study IdentifierNCT04436653
SponsorChanghai Hospital
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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 P 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
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