Trials / Completed
CompletedNCT04380415
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
Fitbit Atrial Fibrillation From PPG Data Validation Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 450,000 (actual)
- Sponsor
- Fitbit LLC · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Single lead ambulatory ECG patch | Single lead ambulatory ECG patch worn on the chest |
Timeline
- Start date
- 2020-05-06
- Primary completion
- 2021-03-08
- Completion
- 2021-03-08
- First posted
- 2020-05-08
- Last updated
- 2021-03-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04380415. Inclusion in this directory is not an endorsement.