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The goal of this study is to validate the Fitbit ECG software algorithm's ability to detect atrial fibrillation using data derived from a Fitbit wrist-worn consumer device that features a single lead ECG. The performance of the software application will be measured against centralized Core Lab physician-adjudicated 12-lead ECG tracings from FDA cleared ECG monitors as reference standards. The Fitbit software is intended as a pre-screening technology. It should identify candidates who may benefit from further evaluation. The software is not intended to be a diagnostic system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: SR | Group 1: Subjects in the sinus rhythm (SR) cohort should not have any history of atrial fibrillation and should not be in atrial fibrillation or other atrial arrhythmia at the time of enrollment based on the screening ECG. |
| |
| Group 2: AF | Group 2: Subjects in the atrial fibrillation (AF) cohort must have a known history of AF and must be in AF at the time of enrollment based on the screening ECG. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrocardiogram | Diagnostic Test | Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the software algorithm's ability to classify a heart rhythm as sinus rhythm or atrial fibrillation from a waveform equivalent to a Lead I ECG. | Sensitivity and specificity of the software algorithm in classifying sinus rhythm and atrial fibrillation from the equivalent of a Lead I ECG waveform, compared with physician's interpretation of a standard 12-lead ECG. Performance goals are 90% (sensitivity) and 92% (specificity) | Through study completion, an average of 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Confirm the software's ability to produce a waveform clinically equivalent to a Lead I ECG from a clinical reference device (12-lead ECG). | Qualitative assessment of the software produced waveform to reference Lead I from 12-lead ECG. Goal is >0.80 of strips appear to overlay to the unaided eye. Comparison of R-wave amplitudes between the Fitbit waveform and the clinical reference. Goal is >0.80 of R-wave amplitudes to be within 2mm. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited at the individual clinical sites. Subjects may be recruited during routine clinic visits or may be asked to come in specifically for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Venkatesh Raman, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States | ||
| Bioclinica Research Orlando |
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| Through study completion, an average of 4 months |
| Orlando |
| Florida |
| 32806 |
| United States |
| Bioclinica Research The Villages | The Villages | Florida | 32162 | United States |
| PMG Research of Dupage | Winfield | Illinois | 60190 | United States |
| PMG Research of McFarland | Ames | Iowa | 50010 | United States |
| PMG Research of Rocky Mount | Rocky Mount | North Carolina | 27804 | United States |
| PMG Research of Piedmont Healthcare | Statesville | North Carolina | 28625 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| PMG Research of Charleston | Mt. Pleasant | South Carolina | 29407 | United States |
| Onassis Cardiac Surgery Center | Kallithea | Greece |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
| D004568 | Electrodiagnosis |
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