Status:
COMPLETED
Validation of Software for Assessment of Atrial Fibrillation From PPG Data Acquired by a Wearable Smartwatch
Lead Sponsor:
Fitbit LLC
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
Validate the Fitbit PPG RhythmDetect Software System algorithm for providing notifications by identifying rhythms suggestive of atrial fibrillation or atrial flutter events.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
450000 Patients enrolled
Trial Details
Trial ID
NCT04380415
Start Date
May 6 2020
End Date
March 8 2021
Last Update
March 9 2021
Active Locations (2)
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1
PlushCare
San Francisco, California, United States, 94107
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114