THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein

Study Overview
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Brief Summary
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The trial aims to evaluate the safety and effectiveness of LuX-Valve transcatheter tricuspid valve and delivery system via jugular vein which are intended to use in symptomatic patients with severe tricuspid regurgitation and high surgical risk.

Detailed Description
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The TRAVEL II study is a prospective multi-center single-arm trial for transcatheter tricuspid valve replacement with LuX-Valve via jugular vein. 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 via jugular vein if an informed consent is obtained.

Official Title
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THE TRAVEL II TRIAL: Transcatheter Right Atrial-ventricular Valve rEplacement With LuX-Valve Via Jugular Vein

Conditions
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Tricuspid Valve Regurgitation

Intervention / Treatment
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* Device: Tricuspid Valve Replacement System via jugular vein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a prospective, multi-center single-arm trial in eight 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.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device or Procedure-Related Adverse Events | 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 | 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 | 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 | 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 | 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) | MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization. | 1 year | 
| Major Adverse Event (MAE) | MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization. | 2 year | 
| Major Adverse Event (MAE) | MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization. | 3 year | 
| Major Adverse Event (MAE) | MAE includes death, myocardial infarction, stroke, reoperation for bleeding, renal failure, pulmonary embolism, gastrointestinal hemorrhage, rehospitalization. | 4 year | 
| Major Adverse Event (MAE) | 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 | 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) | 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) | 6MWT distance is recorded and compared with baseline during follow-up. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid valve regurgitation, Transcatheter tricuspid valve replacement, LuX-Valve