Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fitbit LLC
- Enrollment
- 472
- Locations
- 10
- Primary Endpoint
- 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.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- 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)