Clinical trial NCT03335800: Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
Official title: Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Arrhythmias, Cardiac
Atrial Flutter
Lead sponsor: Apple Inc.
Sponsor class: INDUSTRY
Collaborators: name: Stanford University
First posted: 2017-11-08
Enrollment: 419927
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Atrial Fibrillation (AF) of Greater Than 30 Seconds
timeFrame: During ambulatory ECG monitoring (up to 8 days)
measure: Confirmed AF With a Detection by a Component of the App
timeFrame: During ambulatory ECG monitoring (up to 8 days)
Secondary outcomes:
measure: Concordant AF With App Algorithm Notification
timeFrame: During ambulatory ECG monitoring (up to 8 days)
measure: Self-reported Contact With a Health Care Provider
timeFrame: 90 days to 15 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Minang (Mintu) Turakhia, MD, MAS
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Marco V. Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia A, Balasubramanian V, Lee J, Gardner R, Gummidipundi S, Hung G, Ferris T, Cheung L, Granger C, Kowey P, Rumsfeld J, Russo A, Hills MT, Talati N, Nag D, Stein J, Tsay D, Desai S, Mahaffey K, Turakhia M, Perez M, Hedlin H, Desai M. Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. J Biopharm Stat. 2022 May 4;32(3):496-510. doi: 10.1080/10543406.2022.2080698. Epub 2022 Jun 12.
citation: Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
citation: Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, Desai S, Nag D, Patel M, Kowey P, Rumsfeld JS, Russo AM, Hills MT, Granger CB, Mahaffey KW, Perez MV. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. Am Heart J. 2019 Jan;207:66-75. doi: 10.1016/j.ahj.2018.09.002. Epub 2018 Sep 8.