Cardiovascular Atlas
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Apple Heart Study

A large US study of whether a smartwatch alert for an irregular pulse matches atrial fibrillation on an ECG. People with a compatible iPhone and Apple Watch who reported no atrial fibrillation joined through an app. Those who got an alert were offered a telemedicine visit and a mailed ECG patch. The study checked how often alerts matched the ECG. It did not test whether alerts prevent strokes.

Also called AHS

  • Study
  • In this atlas

Overview

Design
Single-group, siteless, pragmatic study. The registry gives allocation not applicable, one arm, no masking and primary purpose screening. A smartwatch irregular-pulse notification algorithm flagged possible atrial fibrillation, which started a telemedicine visit and a mailed ECG patch to wear for up to 7 days (abstract).
Phase
Not applicable
Enrolled
  • 419,927 participants (enrolled count) (Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias, retrieved )
  • 419,297 participants (enrolled count) (Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation, retrieved )
Sponsor
Funder
Not recorded
Registry
  • NCT NCT03335800
Started
(actual) (Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias, retrieved )
Primary completion
(actual) (Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias, retrieved )
Completion
(actual) (Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias, retrieved )
Results first posted
(Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias, retrieved )
Countries
United States (Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias, retrieved )
Care setting
Remote and siteless. Participants consented through a smartphone app and no on-site visits were required. After an alert, follow-up used a telemedicine visit and a mailed ECG patch. (Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation, retrieved )
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

Single-group, siteless, pragmatic study (NCT03335800), sponsored by Apple Inc. with Stanford University as registry collaborator; the registry names two principal investigators, Mintu Turakhia and Marco V. Perez, both at Stanford. The registry records an interventional study, phase not applicable, allocation not applicable, one arm, no masking and primary purpose screening. Enrollment differs by source: the registry gives 419927 (actual) and the abstract of the NEJM paper says 419,297 participants were recruited. The sources do not explain the difference and it is not reconciled. The registry lists two primary outcomes (AF on ambulatory ECG among notified participants, and confirmed AF with a detection by an app component) and two secondary outcomes (concordance with the app algorithm notification, and self-reported contact with a health care provider). No findings are recorded as structured rows here; the results are in the claim for the technology.

Arms

  • Apple Heart Study App

    Intervention None named

    Participants without self-reported atrial fibrillation used a smartphone app to consent to monitoring. If a smartwatch-based irregular pulse notification algorithm identified possible atrial fibrillation, a telemedicine visit was started and an ECG patch was mailed to wear for up to 7 days.

Findings

No findings are published for this study.

Record details

Record id
cardio:apple-heart-study
Content hash
556e7cae40614b7e6d3030aca2a59377e0a15873478c631c23abed6f0e15b50d