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This study is to collect preliminary chronic information on performance and safety of the ReValve System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm Study | Experimental | Device: ReValve System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReValve System | Device | Mitral Valve Replacement Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Success | The Technical Success, is defined as the successful delivery of the ReValve Palmetto Valve and withdrawal of the delivery system | Procedure |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute Dante Pazzanese of Cardiology - IDPC | Recruiting | São Paulo | São Paulo | SP, 04012-909 | Brazil |
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| The Heart Institute - INCOR | Recruiting | São Paulo | São Paulo | SP, 05403-900 | Brazil |
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