N/A
Completed N=17
Evaluation of the Use of Apple Watch Features for Identification of Cardiac Arrhythmias
Atrial Fibrillation · Arrhythmias, Cardiac · atrial flutter
Source: ClinicalTrials.gov NCT03769207 ↗
Enrolled (actual)
17
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration — 0.11 Proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration |
0.11 | — |
| SECONDARY Arrhythmias Other Than AF |
— | — |
| SECONDARY Self-reported Contact With Healthcare Provider |
0.56 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03769207). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.