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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
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The primary purpose of this clinical trial is to evaluate the efficacy and safety of the transcatheter aortic valve system in the treatment of patients with failing bioprosthetic valve
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prizvalve® system | Device | Transcatheter valve-in-valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause mortality and valve-related reintervention | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success |
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Procedural Success |
| 30 days |
| Device success |
| 30 days |
| All-cause mortality | All-cause mortality included cardiac,non-cardiac death and other ominous death. | 30 days |