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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03335800
• Other study ID #: 1.0
• Status: Completed
• Phase: N/A
• Start date: November 29, 2017
• Est. completion date: February 21, 2019

Study information

• Verified date: March 2020
• Source: Apple Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 419927
• Est. completion date: February 21, 2019
• Est. primary completion date: February 21, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Flutter

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Apple Inc.	Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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

External Links

•   Website for study information