Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
450,000
Single lead ambulatory ECG patch worn on the chest
PlushCare
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
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.
Time frame: 7 days
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.
Time frame: 7 days
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