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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

419927 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-29

Study Completion Date

2019-02-21

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.

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Detailed Description

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Conditions

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Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Apple Heart Study App

Group Type EXPERIMENTAL

Apple Heart Study App

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.