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| ID | Type | Description | Link |
|---|---|---|---|
| MicroPort Medical | Registry Identifier | MicroPort Medical |
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The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for Surgical Valve Replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroPort's Transcatheter Aortic Valve and Delivery System | Experimental | single arm with intervention that percutaneous implantation of the MicroPort's Transcatheter Aortic Valve and Delivery System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MicroPort's Transcatheter Aortic Valve and Delivery System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality or major stroke at 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE(major adverse cardiovascular and cerebrovascular events) | MACCE is defined as a composite of:
| 30 days, 3, 6 and 12 months |
| Device success |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Liu, Medical Doctor | Contact | +86 13911002920 | davidliu@coremed.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| JunBo Ge, Medical Doctor, Professor | Shanghai Zhongshan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | 200032 | China |
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Device success is defined as
|
| 7 days post-operation |
| Valve performance | Valve performance means:
| 30 days, 3, 6 and 12 months |
| The improvement of heart function | 30 days, 3, 6 and 12 months |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| C562942 | Aortic Valve, Calcification of |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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