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This study will be a single center, single arm, open-label, prospective study to evaluate adhesive performance of the Bardy Diagnostics' (BardyDx) MCT Patch up to 30 days of wear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCT device subjects | All subjects are provided MCT system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile Cardiac Telemetry (MCT System) | Device | MCT System without data transmission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative wear time | as measured by ECG readability sufficient for identification of the P and QRS waves; the total readable duration summed from each patch, measured from the start of the first day to the end | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Self-Reported Log & Subject Survey of the MCT Patch after 30 days | skin and adhesive comfort, and device stability and skin contact | 30 days |
| Adverse events of relevance, including potential skin damage due to repeated removal and reapplication of the MCT Patch as determined by Investigator/designee from subject assessments including Subject Logs, Subject Surveys and photos. |
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Inclusion Criteria:
Each subject must meet the following criteria to be enrolled in this study:
Exclusion Criteria:
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A total of 10 healthy evaluable subjects (wearing and returning the test article) consisting of at least 5 males and 5 females is the desired sample size.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orange County Research Center | Lake Forest | California | 92630 | United States |
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| From enrollment to end of study at 30 days. |