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

Apple Inc.1 site in 1 country17 target enrollmentDecember 8, 2018

ConditionsAtrial Fibrillation Arrhythmias, Cardiac Atrial Flutter

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Apple Inc.
Enrollment: 17
Locations: 1
Primary Endpoint: Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 8, 2018

End Date

August 20, 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Apple Inc.

Responsible Party

Principal Investigator

Marco Perez

Assistant Professor of Medicine (Cardiovascular Medicine)

Stanford University

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•Shared iCloud account
•Shared AppleWatch

Outcomes

Primary Outcomes

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 Outcomes

Self-reported Contact With Healthcare Provider(Between 15 to 90 days following enrollment)
Arrhythmias Other Than AF(During ambulatory ECG Monitoring (up to 8 days))