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Previous trials have shown that TAVR was a noninferior alternative to surgery in patients with severe aortic stenosis at intermediate surgical risk. However, patients with congenital bicuspid valve have been excluded in those trials. The purpose of this trial is to determine the safety and effectiveness of TAVR in intermediate-risk patients with bicuspid aortic valve stenosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAVR group | Experimental |
| |
| SAVR group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAVR | Procedure | Transcatheter Aortic Valve Replacement |
| |
| SAVR |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality, all stroke, and re-hospitalization | This composite endpoint will be evaluated as a non-inferiority analysis based on a relative non-inferiority margin of 35% | 1 year post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong-jian Wu, M.D, Ph.D | Contact | 0086-10-88396780 | fuwaihospital@hotmail.com |
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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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| Procedure |
Surgical Aortic Valve Replacement |
|