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The purpose of the study is to confirm the Garmin ECG (electrocardiogram) software algorithm can detect and classify atrial fibrillation and normal sinus rhythm on single lead ECG data derived from a Garmin wrist-worn, consumer device. The study will also confirm the software's ability to create a Lead I ECG that is clinically equivalent to a reference device. The Garmin ECG software is not a diagnostic system and is intended for informational purposes only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atrial fibrillation (AF) | Other | Patients with a known history of AF who are in AF at the time of study screening. |
|
| Normal Sinus Rhythm (SR) | Other | Patients with no known diagnosis of AF or other arrhythmia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram | Diagnostic Test | Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs. |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of rhythm classification | Number of participants with a SR software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG | 1 Day |
| Sensitivity of rhythm classification | Number of participants with an AF software rhythm classification in agreement with a physician's interpretation of heart rhythm based on gold standard 12-lead ECG | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Number of ECGs that pass a visual overlay | Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference | Day 1 |
| Difference in R-wave amplitudes between the software and gold standard reference |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85018 | United States | ||
| MedStar Washington Hospital Center |
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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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| ID | Term |
|---|---|
| D004562 | Electrocardiography |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
Number of participants with software's ability to produce a clinically equivalent waveform in agreement to a gold standard Lead I reference |
| Day 1 |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| HealthEast | Saint Paul | Minnesota | 55102 | United States |
| Northwell Health North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Northwell Health Lenox Hill Hospital | New York | New York | 10075 | United States |
| MedStar Health Cardiac Electrophysiology at Fairfax | Fairfax | Virginia | 22031 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D004568 | Electrodiagnosis |