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NCT04176926 · ClinicalTrials.gov registry record
Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch
A clinical trial, sponsored by Fitbit.
- Completed
- Registry status
- 472
- Enrollment target
NCT04176926: Completed study, sponsored by Fitbit.
NCT04176926 is a clinical trial that has completed, run by Fitbit. The registered enrollment target is 472 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04176926 has completed, sponsored by Fitbit.
- COMPLETED
- Registry status
- 472 participants
- Enrollment target
Study 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.
Primary Outcome
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)
Interventions
- DIAGNOSTIC_TEST Electrocardiogram
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 472 participants |
| Start Date | 2019-10-29 |
| Est. Completion | 2020-03-02 |
What the finished NCT04176926 record still lists
NCT04176926 is an observational study that tracks outcomes without assigning an intervention. The registered 472 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Electrocardiogram is the first listed.
NCT04176926 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04176926 about?
NCT04176926 is a clinical study titled "Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch". 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 physi...
What is the current status of trial NCT04176926?
This trial is currently completed. The enrollment target is 472 participants. The study started on 2019-10-29. Estimated completion is 2020-03-02.
What interventions are being tested in trial NCT04176926?
The interventions under investigation include: Electrocardiogram (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04176926?
This trial is sponsored by Fitbit, which has 4 total clinical trials registered on ClinicalTrials.gov.
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