RecruitingNot ApplicableNCT05194423
THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein
Sponsor
Changhai Hospital
Enrollment
150 participants
Start Date
Mar 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 50 Years
Inclusion Criteria8
- 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 Criteria12
- 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.
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Interventions
DEVICETricuspid Valve Replacement System via jugular vein
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT05194423
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