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

Atrial Fibrillation Clinical Trial

Official title:

Fitbit Atrial Fibrillation From PPG Data Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04380415
• Other study ID #: 129-0469-01
• Status: Completed
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: March 8, 2021

Study information

• Verified date: February 2021
• Source: Fitbit Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450000
• Est. completion date: March 8, 2021
• Est. primary completion date: March 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Diagnostic Test:
• Single lead ambulatory ECG patch
Single lead ambulatory ECG patch worn on the chest

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	PlushCare	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Fitbit Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Simultaneous measurement of AF = 30 seconds with detection	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.	7 days
Secondary	Simultaneous measurement of AF = 30 seconds with pulse tachograms	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.	7 days