THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve
NCT ID: NCT04436653
Last Updated: 2020-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2020-06-16
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tricuspid Valve Replacement System
Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.
Tricuspid Valve Replacement System
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.
Interventions
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Tricuspid Valve Replacement System
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.
Eligibility Criteria
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Inclusion Criteria
2. Subjects or subject's legal representative has been informed of the nature of the study and provided written informed consent.
3. 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.
4. Subjects must guarantee they won't participate in any other clinical trial for a period of one year after the intervention.
5. Subjects are with New York Heart Association (NYHA) Functional Class III or IV.
6. Subjects are with normal left heart function (EF ≥ 50%).
7. No indications for left-sided or pulmonary valve intervention.
8. 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
2. Subjects with previous transcatheter or surgical tricuspid valve procedure.
3. Subjects with tricuspid stenosis or other anatomy disorders that unsuitable for the procedure.
4. Subjects with depressed right heart function (tricuspid annular plane systolic excursion (TAPSE) \< 10mm or right ventricle fractional area change (FAC) \< 20%).
5. 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+).
6. Subjects with active endocarditis or other infectious diseases.
7. Subjects with untreated severe coronary artery disease.
8. Subjects with percutaneous coronary intervention, cerebrovascular accident or surgical intervention within 3 months of the date of the procedure.
9. Subjects with coagulation disorders.
10. Subjects with known allergy, hypersensitivity or contraindication to the material or drugs used in the procedure.
11. Subjects with cognitive disorders that can not cooperate the study or follow-up.
12. Subjects with less than 12 months life expectancy because of non-cardiac conditions.
50 Years
ALL
No
Sponsors
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Fu Wai Hospital, Beijing, China
OTHER
Beijing Anzhen Hospital
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
West China Hospital
OTHER
Xijing Hospital
OTHER
Guangdong Provincial People's Hospital
OTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Changhai Hospital
OTHER
Responsible Party
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Zhiyun Xu
Chair of Department of Cardiovascular Surgery
Principal Investigators
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Zhiyun Xu, MD.
Role: PRINCIPAL_INVESTIGATOR
Changhai Hospital
Shengshou Hu, MD.
Role: STUDY_CHAIR
Fu Wai Hospital
Fanglin Lu, MD.
Role: STUDY_DIRECTOR
Changhai Hospital
Locations
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Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Fu Wai Hospital
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Wuhan Union Hospital
Wuhan, Hubei, China
Xijing Hospital
Xi'an, Shaanxi, China
Changhai Hospital
Shanghai, Shanghai Municipality, China
West China Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xu Meng, MD.
Role: primary
Xiangbin Pan, MD.
Role: primary
Huiming Guo, MD.
Role: primary
Nianguo Dong, MD.
Role: primary
Jian Yang, MD.
Role: primary
Shiqiang Yu, MD.
Role: backup
Zhiyun Xu, MD.
Role: primary
Yingqiang Guo, MD.
Role: primary
Mao Chen, MD.
Role: backup
Jianan Wang, MD.
Role: primary
References
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Pan X, Lu F, Wang Y, Guo Y, Chen M, Meng X, Zhang H, Dong N, Shang X, Yang J, Liu Y, Wang J, Liu X, Guo H, Liu J, Qiao F, Ascione G, Cheung A, Modine T, von Bardeleben RS, Granada JF, Xu Z, Hu S. Transcatheter Tricuspid Valve Replacement With the Novel System: 1-Year Outcomes From the TRAVEL Study. JACC Cardiovasc Interv. 2025 May 26;18(10):1276-1285. doi: 10.1016/j.jcin.2024.12.030. Epub 2025 Apr 9.
Other Identifiers
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TRAVEL
Identifier Type: -
Identifier Source: org_study_id