Trials / Completed
CompletedNCT04176926
Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 472 (actual)
- Sponsor
- Fitbit LLC · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Electrocardiogram | Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm. |
Timeline
- Start date
- 2019-10-29
- Primary completion
- 2019-12-20
- Completion
- 2020-03-02
- First posted
- 2019-11-25
- Last updated
- 2020-04-09
Locations
10 sites across 2 countries: United States, Greece
Source: ClinicalTrials.gov record NCT04176926. Inclusion in this directory is not an endorsement.