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Completed

NCT Number: NCT03335800

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Apple Heart Study App

Device

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Apple Inc.

Industry

Collaborators

  • Stanford University

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2017
Registry last updated
Mar 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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