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

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

Completed

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PlushCare, San Francisco, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single lead ambulatory ECG patch

Diagnostic Test

Single lead ambulatory ECG patch worn on the chest

Primary outcomes

Simultaneous measurement of AF ≥ 30 seconds with detection

Time frame: 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 outcomes

Simultaneous measurement of AF ≥ 30 seconds with pulse tachograms

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fitbit LLC

Industry

Registry information

Official study title

Fitbit Atrial Fibrillation From PPG Data Validation Study

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2021
First posted: May 8, 2020
Registry last updated: Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed