Atrial Fibrillation
Conditions
Brief summary
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
Interventions
DIAGNOSTIC_TESTSingle lead ambulatory ECG patch
Single lead ambulatory ECG patch worn on the chest
Sponsors
Fitbit LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults 22 years of age or older * Capable of giving informed consent * U.S. resident * No prior history of atrial fibrillation or atrial flutter * Fitbit account, with one of the following devices paired: * Ionic, Versa, Versa Lite, Versa 2, Versa 3, Charge 3, Charge 4, Inspire HR, Inspire 2, or Sense updated to the latest available firmware.
Exclusion criteria
* Diagnosis or history of Atrial Fibrillation at time of consent * Diagnosis or history of Atrial Flutter at time of consent * Current use of anticoagulation medication * Cardiac pacemaker or implantable cardioverter-defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simultaneous measurement of AF ≥ 30 seconds with detection | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms | 7 days | 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. |
Countries
United States
Outcome results
None listed