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New treatment option for Tricuspid Valve Regurgitation
Official title THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
ClinicalTrials.gov ID: NCT05194423
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Age ≥ 50 years at time of consent.
- people 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...
- people must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
- people are with New York Heart Association (NYHA) Functional Class III or IV.
You likely can't join if
- people with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
- people with previous transcatheter or surgical tricuspid valve procedure.
- people with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
- people with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) \< 10mm or right ventricle fractional area change...
- people with aortic stenosis (mean ΔP≥ 40mmHg or aortic valve area ≤ 1 cm2), aortic regurgitation (≥ 3+), mitral stenosis (mitral valve area ≤1.5 cm2)...
- people with active endocarditis or other infectious diseases.
See the full eligibility criteria
- Age ≥ 50 years at time of consent.
- people 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.
- people must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
- people are with New York Heart Association (NYHA) Functional Class III or IV.
- people are with normal left heart function (EF ≥ 50%).
- No indications for left-sided or pulmonary valve intervention.
- people 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...
- people with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
- people with previous transcatheter or surgical tricuspid valve procedure.
- people with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
- people with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) \< 10mm or right ventricle fractional area change (FAC) \< 20%).
- people 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+).
- people with active endocarditis or other infectious diseases.
- people with untreated severe coronary artery disease.
- people with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
- people with coagulation disorders.
- people with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
- people with cognitive disorders that can not cooperate the study or follow-up.
- people with less than 12 months life expectancy because of non-cardiac conditions.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Wuhan, Hubei, China; Xi'an, Shaanxi, China; Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.