Status:
RECRUITING
THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Fu Wai Hospital, Beijing, China
Beijing Anzhen Hospital
Conditions:
Tricuspid Valve Insufficiency
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 regurgita...
Detailed 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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04436653
Start Date
June 16 2020
End Date
June 1 2026
Last Update
November 17 2020
Active Locations (8)
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1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
2
Fu Wai Hospital
Beijing, Beijing Municipality, China, 100037
3
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510000
4
Wuhan Union Hospital
Wuhan, Hubei, China, 430000