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

Apple

Status: Completed

Conditions: Atrial Flutter; Atrial Fibrillation; Arrhythmias, Cardiac

Treatments: Device: Ambulatory ECG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03769207

48787 (Other Identifier)

1.2

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Ambulatory ECG

Other group

Treatment:

Device: Ambulatory ECG