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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter
• Intervention / Treatment: Device: Ambulatory ECG

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Ambulatory ECG	Device: Ambulatory ECG; Eligible participants are asked to wear the ambulatory ECG monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration	Detected on ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification	During ambulatory ECG Monitoring (up to 8 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmias Other Than AF	Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification	During ambulatory ECG Monitoring (up to 8 days)
Self-reported Contact With Healthcare Provider		Between 15 to 90 days following enrollment

Collaborators and Investigators

• Sponsor: Apple Inc.
• Investigators: Principal Investigator: Marco V Perez, MD, Stanford University; Principal Investigator: Minang (Mintu) Turakhia, MD, MAS, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2018
• Primary Completion (Actual): July 5, 2019
• Study Completion (Actual): August 20, 2019

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: September 25, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Atrial Fibrillation; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: 1.2; 48787 (Other Identifier: Stanford IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes