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The manufacturer who was to provide the study devices decided not to do so.
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This is a single-center, non-randomized study to collect validation data for submission to the Food and Drug Administration (FDA) to support a 510(k) device clearance for a smartwatch ECG.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screen group | Experimental | This is a single-center, non-randomized open study with a single-patient clinical trial design (i.e., the patients serve as their own control). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| We propose to validate these smartwatch ECG functions to support FDA submissions | Diagnostic Test | 1) Obtain a simultaneous recording of a Lead I (RA-LA) ECG from the Smartwatch and a clinical standard device (GE Cardiosoft ECG). Subsequent recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile. |
| Measure | Description | Time Frame |
|---|---|---|
| QRS amplitude | Recordings will be acquired from the other models of the Smartwatch as well as a recording utilizing the FDA-cleared KardiaMobile. | 30 seconds |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stavros Stavrakis, MD | University of Oklahoma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | 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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We propose to validate these smartwatch ECG functions to support FDA submissions
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| D013568 |
| Pathological Conditions, Signs and Symptoms |