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

Fitbit

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Diagnostic Test: Single lead ambulatory ECG patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT04380415

129-0469-01

Details and patient eligibility

About

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

Enrollment: 450,000 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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450,000 participants in 2 patient groups

Detection Notification

Active Comparator group

Description:

Pulse rate data will be collected from a commercial device worn on the wrist. ECG will be collected from a single lead ambulatory ECG patch worn on the chest. The data from both the commercial wrist-worn device and the ECG patch are not analyzed real-time.

Treatment:

Diagnostic Test: Single lead ambulatory ECG patch

Non Detection Notification

No Intervention group

Description:

Pulse rate data will be collected from a commercial device worn on the wrist.