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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Diagnostic Test: Single lead ambulatory ECG patch

• Registration Number: NCT04380415
• Lead Sponsor: Fitbit LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study Start: 2020-05-06
• Study First Posted: 2020-05-08
• Status Verified: 2021-02
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Detection Notification	Single lead ambulatory ECG patch	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.

Primary Outcome Measures

Name	Time	Method
Simultaneous measurement of AF ≥ 30 seconds with detection	7 days	Simultaneous measurement of AF ≥ 30 seconds on ECG patch monitor during any of the pulse tachograms that generate the first Irregular Heart Rhythm Detection during ECG monitoring.

Secondary Outcome Measures

Name	Time	Method
Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms	7 days	Simultaneous measurement of AF ≥ 30 seconds on the ECG patch monitor during each of the pulse tachograms that contributed to the first Irregular Heart Rhythm Detection, among those detections confirmed by ECG.

Trial Locations

Locations (2)

PlushCare; 🇺🇸 San Francisco, California, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States