Atrial Fibrillation
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTElectrocardiogram
Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm.
Sponsors
Fitbit LLC
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women and men 22 years of age or older * Capable of giving informed consent * Sufficient manual dexterity to capture an ECG from the Fitbit wrist-worn device. * 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
Exclusion criteria
* Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide) * Cardiac pacemaker or implantable cardioverter-defibrillator * History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Through study completion, an average of 4 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Confirm the software's ability to produce a waveform clinically equivalent to a Lead I ECG from a clinical reference device (12-lead ECG). | Through study completion, an average of 4 months | 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. |
Countries
Greece, United States
Outcome results
None listed