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

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Atrial Flutter; Arrhythmias, Cardiac
• Interventions: Device: Ambulatory ECG

• Registration Number: NCT03769207
• Lead Sponsor: Apple Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Study Start: 2018-12-08
• Primary Completion: 2019-07-05
• Study Completion: 2019-08-20
• Status Verified: 2020-09
• Results First Submitted: 2020-09-25
• Results First Submitted QC: 2020-09-25
• Last Update Submitted: 2020-09-25
• Results First Posted: 2020-10-20
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ambulatory ECG	Ambulatory ECG	-

Primary Outcome Measures

Name	Time	Method
Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration	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 Outcome Measures

Name	Time	Method
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)	Detected on an ambulatory ECG patch monitor for a participant who received an IRN or Apple Watch ECG app - AFib classification

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States