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Cited by 474Non-Invasive Vital Sign MonitoringAtrial Fibrillation Management and OutcomesMobile Health and mHealth Applications

Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: the apple heart study

Open access
Turakhia, Mintu P., Desai, Manisha, Hedlin, Haley, Rajmane, Amol, Talati, Nisha, Ferris, Todd, Desai, Sumbul, Nag, Divya +8 more·2019·American Heart Journal
DOI 10.1016/j.ahj.2018.09.002PMC PMC8099048
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Abstract

BACKGROUND: Smartwatch and fitness band wearable consumer electronics can passively measure pulse rate from the wrist using photoplethysmography (PPG). Identification of pulse irregularity or variability from these data has the potential to identify atrial fibrillation or atrial flutter (AF, collectively). The rapidly expanding consumer base of these devices allows for detection of undiagnosed AF at scale. METHODS: The Apple Heart Study is a prospective, single arm pragmatic study that has enrolled 419,093 participants (NCT03335800). The primary objective is to measure the proportion of participants with an irregular pulse detected by the Apple Watch (Apple Inc, Cupertino, CA) with AF on subsequent ambulatory ECG patch monitoring. The secondary objectives are to: 1) characterize the concordance of pulse irregularity notification episodes from the Apple Watch with simultaneously recorded ambulatory ECGs; 2) estimate the rate of initial contact with a health care provider within 3 months after notification of pulse irregularity. The study is conducted virtually, with screening, consent and data collection performed electronically from within an accompanying smartphone app. Study visits are performed by telehealth study physicians via video chat through the app, and ambulatory ECG patches are mailed to the participants. CONCLUSIONS: The results of this trial will provide initial evidence for the ability of a smartwatch algorithm to identify pulse irregularity and variability which may reflect previously unknown AF. The Apple Heart Study will help provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening.

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  • The Apple Heart Study, with 400,000 subjects, demonstrated the power of wearable devices to detect atrial fibrillation using a photoplethysmographic signal in a large group of patients.

    “The Apple Heart Study, with its study size of 40 0,0 0 0 subjects and its ability to detect atrial fibrillation using a photophlethysmographic signal, demonstrated the power of wearable devices to detect rhythm abnormalities in a large group of patients [35] .”

    From Evaluating and managing bradycardia (2020) · cites this paper as [35]

    The Summary describes a study of over 400,000 participants, and the Discussion says it evaluates photoplethysmography-based screening for pulse irregularity that may reveal AF. But this is a rationale-and-design paper: the Summary says the results *will* provide an initial evaluation. It does not report that the study had already demonstrated successful AF detection. (LLM, conf=0.90)

    Experimental — accuracy not yet measured

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Cites

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Research works printed but not linked: 19

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Authors
Turakhia, M. P., Desai, M., Hedlin, H., Rajmane, A., Talati, N., Ferris, T., Desai, S., Nag, D., Patel, M., Kowey, P., Rumsfeld, J. S., Russo, A. M., Hills, M. T., Granger, C. B., Mahaffey, K. W., & Perez, M. V.
Affiliations
  • VA Palo Alto Health Care System (US)
  • Stanford University (US)
  • Apple (United States) (US)
  • Lankenau Heart Institute (US)
  • University of Colorado Anschutz (US)
  • Cooper Medical School of Rowan University (US)
  • StopAfib.org (US)
  • Duke University (US)
  • Stanford Medicine (US)
Corresponding author
  • Turakhia, Mintu P.
  • Perez, Marco V.
ORCID
Venue
American Heart Journal
Publisher
Elsevier BV
Published
2019-01
Volume
207
Pages
66-75
ISSN
0002-8703 (ISSN-L)
DOI
10.1016/j.ahj.2018.09.002
PMC
PMC8099048
OpenAlex
W2899314245
Cited by
474
References
7
Citations by year
2026: 33 · 2025: 65 · 2024: 42 · 2023: 50 · 2022: 60 · 2021: 81 · 2020: 75 · 2019: 65 · 2018: 1 · 2016: 1 · 2012: 1
FWCI
22.19
Type
journal article
Language
en
Open access
Licence
Locations
  • American Heart Journal (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion, cc-by-nc-nd)
Funders
  • Medtronic
  • Bayer Fund
  • National Institutes of Health
  • Gilead Sciences
  • Medtronic Foundation
  • National Heart, Lung, and Blood Institute
  • AbbVie
  • Luitpold Pharmaceuticals
  • American Heart Association
  • Duke University
  • Janssen Pharmaceuticals
  • Sanofi
  • Merck Sharp and Dohme
  • Bristol-Myers Squibb
  • Biosense Webster
  • AstraZeneca
  • CSL Behring
  • GlaxoSmithKline
  • Boston Scientific Corporation
  • Novartis
  • Apple
  • Duke Clinical Research Institute
  • Biotronik
  • Abbott Laboratories
  • AtriCure
  • Boehringer Ingelheim
Topics
  • Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Atrial Fibrillation Management and Outcomes
  • Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
Keywords
atrial fibrillation, atrial flutter, Apple Watch, smartwatches, wearable devices, photoplethysmography, pulse irregularity, Holter monitoring, telemedicine, mobile application, undiagnosed atrial fibrillation
MeSH terms
Smartphone, Patient Reported Outcome Measures, Wearable Electronic Devices, Algorithms, Atrial Fibrillation, Atrial Flutter, Humans, Patient Acceptance of Health Care, Prospective Studies, Time Factors, Electrocardiography, Ambulatory, Telemedicine, Mobile Applications, Pragmatic Clinical Trials as Topic

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