Skip to main content
OpenTrials
Completed

NCT Number: NCT03769207

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Flutter Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Valid phone number associated with iPhone, ascertained from self-report
  • Valid email address, ascertained from self-report

Exclusion criteria

  • Shared iCloud account
  • Shared AppleWatch

Treatment and study plan

Ambulatory ECG

Device

Eligible participants are asked to wear the ambulatory ECG monitor

Primary outcomes

  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 outcomes

  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: Between 15 to 90 days following enrollment

Sponsors and collaborators

Lead sponsor

Apple Inc.

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 7, 2018
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.