THE TRAVEL TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve

NCT04436653 | Recruiting DMC

• 1 other identifier: TRAVEL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

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 regurgitation and high surgical risk.

Conditions

Tricuspid Valve Insufficiency

Keywords

Tricuspid Regurgitation; LuX-Valve; Transcatheter Valve Replacement

Outcome Measures

Primary Outcomes (2)

• Death

  All-cause Death

  1 Year

• Tricuspid Regurgitation Reduction

  Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.

  1 Year

Secondary Outcomes (13)

• Device or Procedure-Related Adverse Events

  1 Year

• Device or Procedure-Related Adverse Events

  2 Year

• Device or Procedure-Related Adverse Events

  3 Year

• Device or Procedure-Related Adverse Events

  4 Year

• Device or Procedure-Related Adverse Events

  5 Year

Study Arms (1)

Tricuspid Valve Replacement System

EXPERIMENTAL

Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.

Device: Tricuspid Valve Replacement System

Interventions

Tricuspid Valve Replacement System DEVICE

To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.

Tricuspid Valve Replacement System

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Fu Wai Hospital, Beijing, China: collaborator
• Beijing Anzhen Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator
• West China Hospital: collaborator
• Xijing Hospital: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (8)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Fu Wai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, 710000, China

RECRUITING

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 40208152 DERIVED

MeSH Terms

Conditions

Tricuspid Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Zhiyun Xu, MD.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Shengshou Hu, MD.

  Fu Wai Hospital

  STUDY CHAIR

• Fanglin Lu, MD.

  Changhai Hospital

  STUDY DIRECTOR

Central Study Contacts

Zhao An, MD.

CONTACT

+8613761420325; anzhao1@yeah.net

Fan Qiao, MD.

CONTACT

+8613564620805; qiaofan@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Cardiovascular Surgery

Model Details: This is a prospective, multi-center single-arm trial in seven centers in China. A minimum of 150 subjects will be enrolled in this study and followed-up at discharge (≤ 10 days post operation), 30 days, 6 months, 1, 2, 3, 4, 5 years.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: June 16, 2020
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)