Validation of Software for Assessment of Atrial Fibrillation From Data Acquired by a Wearable Smartwatch

Completed

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT04176926

Run by

Fitbit LLC

People needed

472

Starts

2019-10-29

Expected to finish

2020-03-02

Last updated by the study team

2020-04-09

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Women and men 22 years of age or older
• Capable of giving informed consent
• Sufficient manual dexterity to capture an ECG from the Fitbit wrist-worn device.
• Subjects in the atrial fibrillation (AF) cohort must have a known history of AF and must be in -AF at the time of enrollment based on the screening ECG

You may not qualify if…

• Anti-arrhythmic (rhythm control) medication use (such as amiodarone or flecainide)
• Cardiac pacemaker or implantable cardioverter-defibrillator
• History of a life-threatening rhythm such as ventricular tachycardia or ventricular fibrillation
• Subjects in the sinus rhythm (SR) cohort should not have any history of atrial fibrillation and should not be in atrial fibrillation or other atrial arrhythmia at the time of enrollment based on the screening ECG

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Bioclinica Research Orlando — Orlando, Florida, United States
• Bioclinica Research The Villages — The Villages, Florida, United States
• PMG Research of Dupage — Winfield, Illinois, United States
• PMG Research of McFarland — Ames, Iowa, United States
• PMG Research of Rocky Mount — Rocky Mount, North Carolina, United States
• PMG Research of Piedmont Healthcare — Statesville, North Carolina, United States
• PMG Research of Wilmington — Wilmington, North Carolina, United States
• PMG Research of Charleston — Mt. Pleasant, South Carolina, United States
• Onassis Cardiac Surgery Center — Kallithea, Greece

Full record on ClinicalTrials.gov

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