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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769207
• Other study ID #: 1.2
• Secondary ID: 48787
• Status: Completed
• Phase: N/A
• Start date: December 8, 2018
• Est. completion date: August 20, 2019

Study information

• Verified date: September 2020
• Source: Apple Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 20, 2019
• Est. primary completion date: July 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Atrial Flutter

Intervention

Device:
• Ambulatory ECG
Eligible participants are asked to wear the ambulatory ECG monitor

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Apple Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Self-reported Contact With Healthcare Provider		Between 15 to 90 days following enrollment