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

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ClinicalTrials.gov Identifier: NCT03335800
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : December 4, 2017
Sponsor:
Information provided by (Responsible Party):
Minang (Mintu) Turakhia, Stanford University

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500000 participants
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
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Atrial Fibrillation (AF) of greater than 30 seconds duration [ Time Frame: During ambulatory ECG monitoring (up to 8 days) ]
    Detected on ambulatory ECG monitoring for a participant who received an irregular pulse watch notification.

  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 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: Up to 15 months ]
    Within 90 days following an irregular pulse watch notification



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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
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.

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


Contacts
Contact: AHS Study Telehealth Provider 1-844-606-1609 appleheartstudy@stanford.edu

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: AHS Study Telehealth Provider    844-606-1609      
Sponsors and Collaborators
Apple Inc.
Investigators
Principal Investigator: Minang (Mintu) Turakhia, MD, MAS Stanford University
Principal Investigator: Marco V. Perez, MD Stanford University

Additional Information:
Responsible Party: Minang (Mintu) Turakhia, Associate Professor of Medicine, Stanford University, Stanford University
ClinicalTrials.gov Identifier: NCT03335800     History of Changes
Other Study ID Numbers: 1.0
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes