Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- Apple Inc.
- Enrollment
- 419927
- Locations
- 1
- Primary Endpoint
- Confirmed AF With a Detection by a Component of the App
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Minang (Mintu) Turakhia
Associate Professor of Medicine, Stanford University
Stanford University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Concordant AF With App Algorithm Notification(During ambulatory ECG monitoring (up to 8 days))
- Self-reported Contact With a Health Care Provider(90 days to 15 months)