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Study protocol for The Heart Watch Study - Prognostic performance of smartwatch 12-lead ECG with advanced ECG analysis in consumer self-screening for cardiovascular disease

Al-Falahi, Zaidon S ; Schlegel, Todd T ; Lee, Vivian ; Chow, Clara K ; Kozor, Rebecca ; Lindow, Thomas LU and Ugander, Martin LU (2026) In American Heart Journal
Abstract

BACKGROUND: It is now possible to acquire a fully diagnostic standard 12-lead electrocardiography (ECG) using a smartwatch, a smartphone app, and no additional hardware. This study aims to evaluate the predictive performance of advanced ECG (A-ECG) analysis applied to a smartwatch 12-lead ECG (SWECG) acquired using an Apple Watch in identifying cardiovascular risks among asymptomatic adults performing consumer self-screening in the general population.

METHODS AND DESIGN: The Heart Watch Study is a prospective, Australia-wide observational cohort study. The study will recruit 30,000 participants aged 20-79 years without prior known cardiovascular disease. Participants will enrol and consent electronically, and download a dedicated... (More)

BACKGROUND: It is now possible to acquire a fully diagnostic standard 12-lead electrocardiography (ECG) using a smartwatch, a smartphone app, and no additional hardware. This study aims to evaluate the predictive performance of advanced ECG (A-ECG) analysis applied to a smartwatch 12-lead ECG (SWECG) acquired using an Apple Watch in identifying cardiovascular risks among asymptomatic adults performing consumer self-screening in the general population.

METHODS AND DESIGN: The Heart Watch Study is a prospective, Australia-wide observational cohort study. The study will recruit 30,000 participants aged 20-79 years without prior known cardiovascular disease. Participants will enrol and consent electronically, and download a dedicated study iPhone app that enables a directed 12-lead SWECG acquisition using an Apple Watch. The recordings will undergo both conventional and A-ECG analysis. Follow-up will be performed through linkage with administrative health datasets in Australia, including hospital visits and mortality. The primary combined endpoint is all-cause mortality, hospitalization for cardiovascular causes, and incident cardiovascular disease (arrythmia, ischemic heart disease, heart failure) as predicted by existing A-ECG analyses.

CONCLUSION: This study evaluates the feasibility of performing a fully diagnostic standard 12-lead SWECG using only a smartwatch and a smartphone application, and addresses the prognostic value of A-ECG machine-learning based analysis in consumer self-screening in a large, diverse and apparently healthy population.

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author
; ; ; ; ; and
organization
publishing date
type
Contribution to journal
publication status
epub
subject
in
American Heart Journal
article number
107619
publisher
Mosby-Elsevier
external identifiers
  • pmid:42805364
ISSN
1097-6744
DOI
10.1016/j.ahj.2026.107619
language
English
LU publication?
yes
additional info
Copyright © 2026. Published by Elsevier Inc.
id
df109441-3e5f-4735-904c-df069f79009b
date added to LUP
2026-09-29 08:40:18
date last changed
2026-09-29 08:45:29
@article{df109441-3e5f-4735-904c-df069f79009b,
  abstract     = {{<p>BACKGROUND: It is now possible to acquire a fully diagnostic standard 12-lead electrocardiography (ECG) using a smartwatch, a smartphone app, and no additional hardware. This study aims to evaluate the predictive performance of advanced ECG (A-ECG) analysis applied to a smartwatch 12-lead ECG (SWECG) acquired using an Apple Watch in identifying cardiovascular risks among asymptomatic adults performing consumer self-screening in the general population.</p><p>METHODS AND DESIGN: The Heart Watch Study is a prospective, Australia-wide observational cohort study. The study will recruit 30,000 participants aged 20-79 years without prior known cardiovascular disease. Participants will enrol and consent electronically, and download a dedicated study iPhone app that enables a directed 12-lead SWECG acquisition using an Apple Watch. The recordings will undergo both conventional and A-ECG analysis. Follow-up will be performed through linkage with administrative health datasets in Australia, including hospital visits and mortality. The primary combined endpoint is all-cause mortality, hospitalization for cardiovascular causes, and incident cardiovascular disease (arrythmia, ischemic heart disease, heart failure) as predicted by existing A-ECG analyses.</p><p>CONCLUSION: This study evaluates the feasibility of performing a fully diagnostic standard 12-lead SWECG using only a smartwatch and a smartphone application, and addresses the prognostic value of A-ECG machine-learning based analysis in consumer self-screening in a large, diverse and apparently healthy population.</p>}},
  author       = {{Al-Falahi, Zaidon S and Schlegel, Todd T and Lee, Vivian and Chow, Clara K and Kozor, Rebecca and Lindow, Thomas and Ugander, Martin}},
  issn         = {{1097-6744}},
  language     = {{eng}},
  month        = {{09}},
  publisher    = {{Mosby-Elsevier}},
  series       = {{American Heart Journal}},
  title        = {{Study protocol for The Heart Watch Study - Prognostic performance of smartwatch 12-lead ECG with advanced ECG analysis in consumer self-screening for cardiovascular disease}},
  url          = {{http://dx.doi.org/10.1016/j.ahj.2026.107619}},
  doi          = {{10.1016/j.ahj.2026.107619}},
  year         = {{2026}},
}