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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter
• Intervention / Treatment: Device: Apple Heart Study App

• Study Type: Interventional
• Enrollment (Actual): 419927
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apple Heart Study App	Device: Apple Heart Study App; The Apple Heart Study app is a mobile medical app that analyzes pulse rate data. The app identifies episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation (AF) of Greater Than 30 Seconds	Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.	During ambulatory ECG monitoring (up to 8 days)
Confirmed AF With a Detection by a Component of the App	Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component (tachogram) is positive for an irregular pulse among those who received an irregular heartbeat notification.	During ambulatory ECG monitoring (up to 8 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordant AF With App Algorithm Notification	Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF when the app based algorithm is positive for an irregular pulse among those who received a notification.	During ambulatory ECG monitoring (up to 8 days)
Self-reported Contact With a Health Care Provider	Percentage of participant who self-reported contact with a health care provider within 90 days following an irregular pulse watch notification. Participants could self-report this health-care provider contact from 90 days following notification until the study survey went offline at end of study.	90 days to 15 months

Collaborators and Investigators

• Sponsor: Apple Inc.
• Collaborators: Stanford University
• Investigators: Principal Investigator: Minang (Mintu) Turakhia, MD, MAS, Stanford University; Principal Investigator: Marco V. Perez, MD, Stanford University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• Website for study information

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): February 21, 2019
• Study Completion (Actual): February 21, 2019

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 8, 2017

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: 1.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes