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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
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To evaluate the safety and performance of the Prizvalve® system in patients with severe atrioventricular annular calcification or failed prosthetic atrioventricular valve/ annulus repair.
The Prizvalve® study is a single-center, single-arm, prospective, exploratory clinical study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Transcatheter atrioventricular valve replacement with the Prizvalve® system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prizvalve® system | Device | Transcatheter atrioventricular valve replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Definition:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success |
|
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1. Inclusion criteria for patients with severe atrioventricular valve annular calcification:
2. Inclusion criteria for patients with failed prosthetic atrioventricular valve/annulus repair:
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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| 30 days,1 year |
| Device success | Definitions:
| 30 days,1 year |
| All-cause mortality | All-cause mortality included cardiac and non-cardiac death. | 30 days,1 year |