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

Not Applicable

Completed

• Conditions: Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Interventions: Device: Apple Heart Study App

• Registration Number: NCT03335800
• Lead Sponsor: Apple Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-02
• Study First Submitted QC: 2017-11-06
• Study First Posted: 2017-11-08
• Study Start: 2017-11-29
• Primary Completion: 2019-02-21
• Study Completion: 2019-02-21
• Results First Submitted: 2020-02-22
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-18
• Last Update Submitted: 2020-03-18
• Results First Posted: 2020-03-30
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 419927

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Apple Heart Study App	Apple Heart Study App	-

Primary Outcome Measures

Name	Time	Method
Confirmed AF With a Detection by a Component of the App	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	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 Outcome Measures

Name	Time	Method
Concordant AF With App Algorithm Notification	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	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States