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Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias

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ClinicalTrials.gov Identifier: NCT03769207
Recruitment Status : Enrolling by invitation
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Marco Perez, Stanford University

Brief Summary:
This post-marketing study is conducted to characterize the ability of Apple Watch rhythm analysis software to identify Atrial Fibrillation (AF) and facilitate subsequent clinical evaluation among users who contact AppleCare.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Device: Ambulatory ECG Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
Actual Study Start Date : December 6, 2018
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ambulatory ECG Device: Ambulatory ECG
Eligible participants are asked to wear the ambulatory ECG monitor




Primary Outcome Measures :
  1. Atrial Fibrillation or Atrial Flutter (AF) of at least 30 seconds duration [ Time Frame: During ambulatory ECG Monitoring (up to 8 days) ]
    Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification


Secondary Outcome Measures :
  1. Arrhythmias other than AF [ Time Frame: During ambulatory ECG Monitoring (up to 8 days) ]
    Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

  2. Self-reported contact with healthcare provider [ Time Frame: Within 60 days following enrollment ]


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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:

  1. Possession of the following at time of eligibility screening:

    • iPhone (5s or later) with iOS version 12.1.1 or later defined as iPhone model/iOS version used to complete screening eligibility.
    • Apple Watch (Series 1-4) with watchOS version 5.1.2 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility
  2. At least one of the following by self-report before consent:

    • Irregular Rhythm Notification
    • ECG app classification of Atrial Fibrillation
    • ECG app classification of Inconclusive defined as "Inconclusive," "Heart Rate Over 120," or "Heart Rate Under 50"
  3. Age ≥ 22 years at time of eligibility screening
  4. Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
  5. Proficient in written and spoken English
  6. Valid phone number associated with iPhone, ascertained from self-report
  7. Valid email address, ascertained from self-report

Exclusion Criteria:

  1. Shared iCloud account
  2. Shared AppleWatch

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): NCT03769207


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

Responsible Party: Marco Perez, Assistant Professor of Medicine (Cardiovascular Medicine), Stanford University
ClinicalTrials.gov Identifier: NCT03769207     History of Changes
Other Study ID Numbers: 1.2
48787 ( Other Identifier: Stanford IRB )
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
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: No
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