Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias

Study Overview
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Brief Summary
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The Apple Heart Study (AHS) is a research study conducted to evaluate whether the Apple Heart Study App can use data collected on the Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. Up to 500,000 can participate in the study.

Official Title
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Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias

Conditions
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Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter

Intervention / Treatment
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* Device: Apple Heart Study App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check: iPhone (5s or later) with iOS version 11.0 or later defined as iPhone model/iOS version used to complete screening eligibility. Apple Watch (Series 1 or later) with watchOS version 4.0 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility. Current resident of the United States at time of eligibility screening, defined by self-reported state of residence within the 50 states of the United States or District of Columbia. Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone. Valid phone number associated with iPhone, ascertained from self-report. Valid email address, ascertained from self-report. Exclusion Criteria: Self-reported diagnosis of Atrial Fibrillation. Self-reported diagnosis of Atrial Flutter. Currently on anti-coagulation therapy.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apple Heart Study App<br> | Device: Apple Heart Study App<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial Fibrillation (AF) of Greater Than 30 Seconds | Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG. | During ambulatory ECG monitoring (up to 8 days) | 
| Confirmed AF With a Detection by a Component of the App | 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. | During ambulatory ECG monitoring (up to 8 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordant AF With App Algorithm Notification | 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. | During ambulatory ECG monitoring (up to 8 days) | 
| Self-reported Contact With a Health Care Provider | 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. | 90 days to 15 months |