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Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Detection Notification | Active Comparator | Pulse rate data will be collected from a commercial device worn on the wrist. ECG will be collected from a single lead ambulatory ECG patch worn on the chest. The data from both the commercial wrist-worn device and the ECG patch are not analyzed real-time. |
|
| Non Detection Notification | No Intervention | Pulse rate data will be collected from a commercial device worn on the wrist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single lead ambulatory ECG patch | Diagnostic Test | Single lead ambulatory ECG patch worn on the chest |
|
| Measure | Description | Time Frame |
|---|---|---|
| Simultaneous measurement of AF ≥ 30 seconds with detection | Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms | Simultaneous measurement of AF ≥ 30 seconds on the ECG patch monitor during each of the pulse tachograms that contributed to the first Irregular Heart Rhythm Detection, among those detections confirmed by ECG. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Lubitz, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PlushCare | San Francisco | California | 94107 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40557492 | Derived | Lubitz SA, McConnell MV, Selvaggi C, Krishnamoorthy A, Atlas SJ, McManus DD, Pagoto S, Singer DE, Pantelopoulos A, Foulkes AS, Faranesh AZ. Wearable Irregular Heart Rhythm Detection Recurrences and Electrocardiographic Atrial Fibrillation Confirmation: The Fitbit Heart Study. Circ Arrhythm Electrophysiol. 2025 Jul;18(7):e013565. doi: 10.1161/CIRCEP.124.013565. Epub 2025 Jun 25. | |
| 36148649 |
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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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| Boston |
| Massachusetts |
| 02114 |
| United States |
| Derived |
| Lubitz SA, Faranesh AZ, Selvaggi C, Atlas SJ, McManus DD, Singer DE, Pagoto S, McConnell MV, Pantelopoulos A, Foulkes AS. Detection of Atrial Fibrillation in a Large Population Using Wearable Devices: The Fitbit Heart Study. Circulation. 2022 Nov 8;146(19):1415-1424. doi: 10.1161/CIRCULATIONAHA.122.060291. Epub 2022 Sep 23. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |