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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335800
Recruitment Status : Completed
First Posted : November 8, 2017
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Stanford University
Information provided by (Responsible Party):
Minang (Mintu) Turakhia, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Device: Apple Heart Study App Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 419927 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
Actual Study Start Date : November 29, 2017
Actual Primary Completion Date : February 21, 2019
Actual Study Completion Date : February 21, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Atrial Fibrillation (AF) of Greater Than 30 Seconds [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]
    Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.

  2. Confirmed AF With a Detection by a Component of the App [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]
    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.


Secondary Outcome Measures :
  1. Concordant AF With App Algorithm Notification [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]
    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.

  2. Self-reported Contact With a Health Care Provider [ Time Frame: 90 days to 15 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335800


Locations
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United States, California
Stanford University
Stanford, California, United States, 94304
Sponsors and Collaborators
Apple Inc.
Stanford University
Investigators
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Principal Investigator: Minang (Mintu) Turakhia, MD, MAS Stanford University
Principal Investigator: Marco V. Perez, MD Stanford University
  Study Documents (Full-Text)

Documents provided by Minang (Mintu) Turakhia, Stanford University:
Study Protocol and Statistical Analysis Plan  [PDF] March 20, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Minang (Mintu) Turakhia, Associate Professor of Medicine, Stanford University, Stanford University
ClinicalTrials.gov Identifier: NCT03335800    
Other Study ID Numbers: 1.0
First Posted: November 8, 2017    Key Record Dates
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Atrial Flutter
 Heart Diseases
Cardiovascular Diseases
Pathologic Processes