Status:
COMPLETED
Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
Lead Sponsor:
Apple Inc.
Conditions:
Atrial Fibrillation
Arrhythmias, Cardiac
Eligibility:
All Genders
22+ years
Phase:
NA
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 user...
Eligibility Criteria
Inclusion
- 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
- 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"
- Age ≥ 22 years at time of eligibility screening
- Current resident of the United States at time of eligibility screening, and will reside in the United States for the length of the study
- Proficient in written and spoken English
- Valid phone number associated with iPhone, ascertained from self-report
- Valid email address, ascertained from self-report
Exclusion
- Shared iCloud account
- Shared AppleWatch
Key Trial Info
Start Date :
December 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2019
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT03769207
Start Date
December 8 2018
End Date
August 20 2019
Last Update
October 20 2020
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94304