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

November 16, 2020 updated by: Zhiyun Xu, Changhai Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 determine whether a subject has severe tricuspid regurgitation with high surgical risk. Subjects who meet the criteria will then receive LuX-Valve implantation if an informed consent is obtained.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
          • Xu Meng, MD.
          • Phone Number: 010-64456260
          • Email: mxu@263.net
      • Beijing, Beijing, China, 100037
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Wuhan Union Hospital
        • Contact:
    • Shaanxi
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • West China Hospital
        • Contact:
          • Yingqiang Guo, MD.
          • Phone Number: +86 028 85421833
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥ 50 years at time of consent.
  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:

  1. Subjects with pulmonary hypertension (systolic pressure ≥ 55mmHg determined by right heart catheterization).
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tricuspid Valve Replacement System
Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.
Device: Tricuspid Valve Replacement System
To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 1 Year
All-cause Death
1 Year
Tricuspid Regurgitation Reduction
Time Frame: 1 Year
Tricuspid regurgitation measured with echocardiography in core lab reduces at least 2 grades.
1 Year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device or Procedure-Related Adverse Events
Time Frame: 1 Year
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
1 Year
Device or Procedure-Related Adverse Events
Time Frame: 2 Year
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
2 Year
Device or Procedure-Related Adverse Events
Time Frame: 3 Year
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
3 Year
Device or Procedure-Related Adverse Events
Time Frame: 4 Year
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
4 Year
Device or Procedure-Related Adverse Events
Time Frame: 5 Year
Device related mortality, device malposition, right ventricular outflow tract obstruction, conduction system disturbances, new onset shunt across ventricular septum, coronary artery injury, valve failure, convert to open surgery, reintervention, embolization.
5 Year
Major Adverse Event (MAE)
Time Frame: 1 Year
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
1 Year
Major Adverse Event (MAE)
Time Frame: 2 Year
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
2 Year
Major Adverse Event (MAE)
Time Frame: 3 Year
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
3 Year
Major Adverse Event (MAE)
Time Frame: 4 Year
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
4 Year
Major Adverse Event (MAE)
Time Frame: 5 Year
MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
5 Year
Functional Change in New York Heart Association (NYHA) Classification
Time Frame: 1 Year
Subjects' heart function is ranged from NYHA I to IV based on how much a patient is limited during physical activity. NYHA I means no limited on physical activity while NYHA IV means unable to take any physical activity.
1 Year
Change in Quality of Life (QOL) is evaluated with Kansas City Cardiomyopathy (KCCQ)
Time Frame: 1 Year
KCCQ score ranges from 0 to 100, which 0 reflects the worst health status and 100 reflects the best health status.
1 Year
Change in Quality of Life (QOL) is evaluated with Six Minute Walk Test (6MWT)
Time Frame: 1 Year
6MWT distance is recorded and compared with baseline during follow-up.
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Collaborators

Xijing Hospital
West China Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Guangdong Provincial People's Hospital
Beijing Anzhen Hospital
Wuhan Union Hospital, China
Fu Wai Hospital, Beijing, China

Investigators

  • Principal Investigator: Zhiyun Xu, MD., Changhai Hospital
  • Study Chair: Shengshou Hu, MD., Fu Wai Hospital
  • Study Director: Fanglin Lu, MD., Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2020

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

June 1, 2026

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRAVEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tricuspid Valve Insufficiency

Clinical Trials on Tricuspid Valve Replacement System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe