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This is a prospective, non-randomized study to refine the Study Watch's algorithm for AF detection within both persistent and paroxysmal AF subjects. The study will also collect data from an FDA-cleared wearable ECG sensor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Watch | Device | Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data |
|
| Measure | Description | Time Frame |
|---|---|---|
| Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF) | Sensitivity estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm | At least 60 minutes |
| PPG- and ECG-based continuous AF-detection algorithms on Study Watch in a free-living (home) setting by comparing the Study Watch data with an FDA-cleared wearable ECG sensor data. | Number of AF events identified from FDA-cleared ECG Device | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Estimate of the accuracy of algorithm based PPG irregular rhythm detection in a study population with a history of paroxysmal or persistent atrial fibrillation (AF) | Predictive value estimate for PPG irregular rhythm detection vs. a multi-lead Holter ECG rhythm | At least 60 minutes |
| Spontaneously-reported participant usability feedback for Study Watch and its ECG feature in a free-living (home) setting with the target AF population. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with a known history of AF (including persistent or paroxysmal AF)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Cardiac Center | San Diego | California | 92123 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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Qualitative listing of participant-reported feedback |
| 14 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |