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| Name | Class |
|---|---|
| Fu Wai Hospital, Beijing, China | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tricuspid Valve Replacement System | Experimental | Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system will be included in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid Valve Replacement System | Device | To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhao An, MD. | Contact | +8613761420325 | anzhao1@yeah.net | |
| Fan Qiao, MD. | Contact | +8613564620805 | qiaofan@smmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhiyun Xu, MD. | Changhai Hospital | Principal Investigator |
| Shengshou Hu, MD. | Fu Wai Hospital | Study Chair |
| Fanglin Lu, MD. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40208152 | Derived | 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. |
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| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| West China Hospital |
| OTHER |
| Xijing Hospital | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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.
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| 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 |
| Changhai Hospital |
| Study Director |
| Fu Wai Hospital | Recruiting | Beijing | Beijing Municipality | 100037 | China |
|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510000 | China |
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| Wuhan Union Hospital | Recruiting | Wuhan | Hubei | 430000 | China |
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| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710000 | China |
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| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
|
| West China Hospital | Recruiting | Chengdu | Sichuan | 610000 | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|