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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2026

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.

Interventions

  • Device: Tricuspid Valve Replacement System
    • To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.

Arms, Groups and Cohorts

  • Experimental: Tricuspid Valve Replacement System
    • Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Major Adverse Event (MAE)
    • Time Frame: 1 Year
    • MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
  • Major Adverse Event (MAE)
    • Time Frame: 2 Year
    • MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
  • Major Adverse Event (MAE)
    • Time Frame: 3 Year
    • MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
  • Major Adverse Event (MAE)
    • Time Frame: 4 Year
    • MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
  • Major Adverse Event (MAE)
    • Time Frame: 5 Year
    • MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Changhai Hospital
  • Collaborator
    • Fu Wai Hospital, Beijing, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhiyun Xu, Chair of Department of Cardiovascular Surgery – Changhai Hospital
  • Overall Official(s)
    • Zhiyun Xu, MD., Principal Investigator, Changhai Hospital
    • Shengshou Hu, MD., Study Chair, Fu Wai Hospital
    • Fanglin Lu, MD., Study Director, Changhai Hospital
  • Overall Contact(s)
    • Zhao An, MD., +8613761420325, anzhao1@yeah.net

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