RecruitingNot ApplicableNCT04436653
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
Sponsor
Changhai Hospital
Enrollment
150 participants
Start Date
Jun 16, 2020
Study Type
INTERVENTIONAL
Conditions
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.
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
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT04436653
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