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TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ArcFlex Sheath | Experimental | ArcFlex Sheath |
|
| control group | Placebo Comparator | The ordinary sheath |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ArcFlex Sheath | Device | TAVR is a crucial treatment method for aortic valve diseases. The requirements for the device to cross the aortic arch and for the bioprosthetic valve to be coaxial are quite high, and they are key steps for the success of the surgery. Investigators' aim is to evaluate the safety and effectiveness of a variable-bend sheath for the TAVR procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| surgical instruments | The success rate of immediate surgical instruments | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality rate | 30-day mortality rate | 30days |
| One-year mortality rate | One-year mortality rate | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaodong zhuang, MD | Contact | 020-89998001 | zhuangxd3@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39869394 | Result | Mao Y, Liu Y, Zhai M, Jin P, Chen F, Yang Y, Zhu G, Yang T, Zhang G, Xu K, Shang X, Zhao Y, Ni B, Li H, Tang M, Jian Z, Yang Y, Zhang H, Wei L, Liu J, Noterdaeme T, Lange R, Guo Y, Pan X, Wu Y, Yang J. Clinical value of aortic arch morphology in transfemoral TAVR: artificial intelligence evaluation. Int J Surg. 2025 Mar 1;111(3):2338-2347. doi: 10.1097/JS9.0000000000002232. |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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|
| ordinary sheath | Device | ordinary sheath |
|