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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 : Completed
First Posted : November 8, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Minang (Mintu) Turakhia, Stanford University

Tracking Information
First Submitted Date  ICMJE November 2, 2017
First Posted Date  ICMJE November 8, 2017
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE November 29, 2017
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03335800 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2017)
  • 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.
  • Self-reported contact with a health care provider [ Time Frame: Up to 15 months ]
    Within 90 days following an irregular pulse watch notification
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
Official Title  ICMJE Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE
  • Atrial Fibrillation
  • Arrhythmias, Cardiac
  • Atrial Flutter
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Apple Heart Study App
Intervention: Device: Apple Heart Study App
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2019)
419297
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 21, 2019
Actual Primary Completion Date February 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03335800
Other Study ID Numbers  ICMJE 1.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Minang (Mintu) Turakhia, Stanford University
Study Sponsor  ICMJE Apple Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Minang (Mintu) Turakhia, MD, MAS Stanford University
Principal Investigator: Marco V. Perez, MD Stanford University
PRS Account Apple Inc.
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP