Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
Public ClinicalTrials.gov record NCT04176926. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04176926
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 472 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 28, 2019
- Primary completion
- Dec 19, 2019
- Completion
- Mar 1, 2020
- Last update posted
- Apr 8, 2020
2019 – 2020
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Bioclinica Research Orlando | Orlando | Florida | 32806 | — |
| Bioclinica Research The Villages | The Villages | Florida | 32162 | — |
| PMG Research of Dupage | Winfield | Illinois | 60190 | — |
| PMG Research of McFarland | Ames | Iowa | 50010 | — |
| PMG Research of Rocky Mount | Rocky Mount | North Carolina | 27804 | — |
| PMG Research of Piedmont Healthcare | Statesville | North Carolina | 28625 | — |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | — |
| PMG Research of Charleston | Mt. Pleasant | South Carolina | 29407 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04176926, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2020 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04176926 live on ClinicalTrials.gov.