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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Fu Wai Hospital, Beijing, China | OTHER |
| Beijing Anzhen Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tricuspid Valve Replacement System via jugular vein | Experimental | Subjects who received transcatheter tricuspid valve replacement with LuX-Valve and delivery system via jugular vein will be included in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tricuspid Valve Replacement System via jugular vein | Device | To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system via jugular vein. |
| 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 | |
|---|---|---|---|---|
| Fan Qiao, MD | Contact | +8613564620805 | qiaofan@smmu.edu.cn | |
| Fan Yang, MD | Contact | +8618321785183 | dearyangf@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhiyun Xu, MD | Changhai Hospital | Principal Investigator |
| Fanglin Lu, MD | Changhai Hospital | Study Director |
| Junbo Ge, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100029 | China |
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| OTHER |
| 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 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.
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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 |
| Shanghai Zhongshan Hospital |
| Principal Investigator |
| Shengshou Hu, MD | Chinese Academy of Medical Sciences, Fuwai Hospital | Principal Investigator |
| Fu Wai Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100037 | China |
|
| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | 510000 | China |
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| Wuhan Union Hospital | Not yet recruiting | Wuhan | Hubei | 430000 | China |
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| Xijing Hospital | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
|
| Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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| Shanghai Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| West China Hospital | Not yet recruiting | Chengdu | Sichuan | 610000 | China |
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| The Second Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| ID | Term |
|---|---|
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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