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

A

Apple

Status

Completed

Conditions

Atrial Flutter
Atrial Fibrillation
Arrhythmias, Cardiac

Treatments

Device: Apple Heart Study App

Study type

Interventional

Funder types

Other
Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

419,927 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

419,927 participants in 1 patient group

Apple Heart Study App
Experimental group
Treatment:
Device: Apple Heart Study App

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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