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The objective of this PAS is to demonstrate the continued safety and clinical effectiveness of the Jewel P-WCD.
This study is an observational registry study of the Jewel P-WCD in post-market use
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This study is an observational registry study of the Jewel P-WCD in post-market use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| This study is an observational registry study of the Jewel P-WCD in post-market use | Other | This study is an observational registry study of the Jewel P-WCD in post-market use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of VT/VF events successfully detected by the Jewel P-WCD | From enrollment to the end of treatment at approximately 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patient population who are at elevated risk of Sudden Cardiac Arrest (SAC) while they wait for permanent diagnosis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| VP, Regulatory Affairs and Quality | Contact | 408-212-1516 | vis@elementsci.com |
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| Jewel | Other | This study is an observational registry study of the Jewel P-WCD in post-market use |
|