Trials / Completed
CompletedNCT04546763
Study Watch AF Detection At Home
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 117 (actual)
- Sponsor
- Verily Life Sciences LLC · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch PPG algorithm in detecting irregular rhythms suggestive of atrial fibrillation (AF) in subjects at risk of having an event of AF in the free living (home) environment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Study Watch | The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics. |
| DEVICE | Zio XT | The Zio XT Patch, the reference device, is a FDA-cleared single-patient use, continuously recording ECG monitor that can be worn up to 14 days. |
Timeline
- Start date
- 2020-09-03
- Primary completion
- 2021-05-14
- Completion
- 2021-05-14
- First posted
- 2020-09-14
- Last updated
- 2021-10-06
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04546763. Inclusion in this directory is not an endorsement.