Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
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|ClinicalTrials.gov Identifier: NCT03335800|
Recruitment Status : Completed
First Posted : November 8, 2017
Results First Posted : March 17, 2020
Last Update Posted : March 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter||Device: Apple Heart Study App||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||419927 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias|
|Actual Study Start Date :||November 29, 2017|
|Actual Primary Completion Date :||February 21, 2019|
|Actual Study Completion Date :||February 21, 2019|
|Experimental: Apple Heart Study App||
Device: Apple Heart Study App
The Apple Heart Study app is a mobile medical app that analyzes pulse rate data. The app identifies episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
- Atrial Fibrillation (AF) of Greater Than 30 Seconds [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.
- Confirmed AF With a Detection by a Component of the App [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component (tachogram) is positive for an irregular pulse among those who received an irregular heartbeat notification.
- Concordant AF With App Algorithm Notification [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF when the app based algorithm is positive for an irregular pulse among those who received a notification.
- Self-reported Contact With a Health Care Provider [ Time Frame: 90 days to 15 months ]Percentage of participant who self-reported contact with a health care provider within 90 days following an irregular pulse watch notification. Participants could self-report this health-care provider contact from 90 days following notification until the study survey went offline at end of study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335800
|United States, California|
|Stanford, California, United States, 94304|
|Principal Investigator:||Minang (Mintu) Turakhia, MD, MAS||Stanford University|
|Principal Investigator:||Marco V. Perez, MD||Stanford University|