Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
Conditions
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.
Interventions
DEVICEAmbulatory ECG
Eligible participants are asked to wear the ambulatory ECG monitor
Sponsors
Apple Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Self-reported Contact With Healthcare Provider | Between 15 to 90 days following enrollment | — |
Countries
United States
Participant flow
Recruitment details
Participants who received an irregular pulse notification or who had an AF classification on the ECG app and then called the sponsor's customer support were invited to download the study app and enroll. They had a remote study visit, were sent an ECG patch to wear and return for analysis, and had a second remote visit to review the findings.
Participants by arm
| Arm | Count |
|---|---|
| Ambulatory ECG Ambulatory ECG: Eligible participants are asked to wear the ambulatory ECG monitor | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Ambulatory ECG |
|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 16.1 |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Middle Eeastern or North African | 1 Participants |
| Race/Ethnicity, Customized Preferred not to respond | 1 Participants |
| Race/Ethnicity, Customized White | 14 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 4 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
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
Time frame: During ambulatory ECG Monitoring (up to 8 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ambulatory ECG | Atrial Fibrillation or Atrial Flutter (AF) of at Least 30 Seconds Duration | 0.11 Proportion of participants |
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
Time frame: During ambulatory ECG Monitoring (up to 8 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ambulatory ECG | Arrhythmias Other Than AF | 0 Proportion of participants |
Secondary
Self-reported Contact With Healthcare Provider
Time frame: Between 15 to 90 days following enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ambulatory ECG | Self-reported Contact With Healthcare Provider | 0.56 Proportion of participants |