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

Completed · Not applicable

Conditions studied: Atrial Fibrillation

In brief

Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.

Key facts

Study ID

NCT04380415

Run by

Fitbit LLC

People needed

450000

Starts

2020-05-06

Expected to finish

2021-03-08

Last updated by the study team

2021-03-09

Who can join

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

You may qualify if…

• Adults 22 years of age or older
• Capable of giving informed consent
• U.S. resident
• No prior history of atrial fibrillation or atrial flutter
• Fitbit account, with one of the following devices paired:
• Ionic, Versa, Versa Lite, Versa 2, Versa 3, Charge 3, Charge 4, Inspire HR, Inspire 2, or Sense updated to the latest available firmware.

You may not qualify if…

• Diagnosis or history of Atrial Fibrillation at time of consent
• Diagnosis or history of Atrial Flutter at time of consent
• Current use of anticoagulation medication
• Cardiac pacemaker or implantable cardioverter-defibrillator

Where it is running

• PlushCare — San Francisco, California, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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