Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
Conditions
Brief summary
The Apple Heart Study (AHS) is a research study conducted to evaluate whether the Apple Heart Study App can use data collected on the Apple Watch to identify irregular heart rhythms, including those from potentially serious heart conditions such as atrial fibrillation. Up to 500,000 can participate in the study.
Interventions
DEVICEApple Heart Study App
The Apple Heart Study app is a mobile medical app that analyzes pulse rate data. The app identifies episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
Sponsors
Stanford University
Apple Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check: * iPhone (5s or later) with iOS version 11.0 or later defined as iPhone model/iOS version used to complete screening eligibility. * Apple Watch (Series 1 or later) with watchOS version 4.0 or later defined as Apple Watch model/watchOS paired with iPhone used to complete screening eligibility. * Current resident of the United States at time of eligibility screening, defined by self-reported state of residence within the 50 states of the United States or District of Columbia. * Proficient in written and spoken English, defined by self-report of comfort reading, writing, and speaking English on iPhone. * Valid phone number associated with iPhone, ascertained from self-report. * Valid email address, ascertained from self-report.
Exclusion criteria
* Self-reported diagnosis of Atrial Fibrillation. * Self-reported diagnosis of Atrial Flutter. * Currently on anti-coagulation therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Atrial Fibrillation (AF) of Greater Than 30 Seconds | During ambulatory ECG monitoring (up to 8 days) | Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG. |
| Confirmed AF With a Detection by a Component of the App | During ambulatory ECG monitoring (up to 8 days) | Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component (tachogram) is positive for an irregular pulse among those who received an irregular heartbeat notification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordant AF With App Algorithm Notification | During ambulatory ECG monitoring (up to 8 days) | Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF when the app based algorithm is positive for an irregular pulse among those who received a notification. |
| Self-reported Contact With a Health Care Provider | 90 days to 15 months | Percentage of participant who self-reported contact with a health care provider within 90 days following an irregular pulse watch notification. Participants could self-report this health-care provider contact from 90 days following notification until the study survey went offline at end of study. |
Countries
United States
Participant flow
Recruitment details
Participants downloaded the app; those with irregular pulse notification had a first teleconference visit with telehealth provider; an ECG patch was shipped to eligible participants to wear for 7 days, then they returned the patch for analysis and had a second teleconference visit to review the findings with the telehealth provider.
Participants by arm
| Arm | Count |
|---|---|
| Apple Heart Study (AHS) App Users Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias. | 419,927 |
| Total | 419,927 |
Baseline characteristics
| Characteristic | Apple Heart Study (AHS) App Users |
|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized American Indian | 4696 Participants |
| Race/Ethnicity, Customized Asian | 26156 Participants |
| Race/Ethnicity, Customized Black | 32275 Participants |
| Race/Ethnicity, Customized Hispanic | 48775 Participants |
| Race/Ethnicity, Customized Middle Eastern | 3652 Participants |
| Race/Ethnicity, Customized Not Reported | 8102 Participants |
| Race/Ethnicity, Customized Other or mixed race | 7958 Participants |
| Race/Ethnicity, Customized Pacific Islander | 1493 Participants |
| Race/Ethnicity, Customized White | 286190 Participants |
| Region of Enrollment United States | 419927 Participants |
| Sex/Gender, Customized Female | 177087 Participants |
| Sex/Gender, Customized Male | 238700 Participants |
| Sex/Gender, Customized Not Reported | 3114 Participants |
| Sex/Gender, Customized Other | 396 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 419,927 |
| other Total, other adverse events | 0 / 419,927 |
| serious Total, serious adverse events | 62 / 419,927 |
Outcome results
Primary
Atrial Fibrillation (AF) of Greater Than 30 Seconds
Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.
Time frame: During ambulatory ECG monitoring (up to 8 days)
Population: Participant who returned ECG Patch
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apple Heart Study (AHS) App Users | Atrial Fibrillation (AF) of Greater Than 30 Seconds | 0.34 Proportion of participants |
Primary
Confirmed AF With a Detection by a Component of the App
Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF during time intervals when an app component (tachogram) is positive for an irregular pulse among those who received an irregular heartbeat notification.
Time frame: During ambulatory ECG monitoring (up to 8 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apple Heart Study (AHS) App Users | Confirmed AF With a Detection by a Component of the App | 0.71 Proportion of Tachograms with AF |
Secondary
Concordant AF With App Algorithm Notification
Simultaneous ambulatory ECG monitoring indicating an irregular rhythm consistent with AF when the app based algorithm is positive for an irregular pulse among those who received a notification.
Time frame: During ambulatory ECG monitoring (up to 8 days)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apple Heart Study (AHS) App Users | Concordant AF With App Algorithm Notification | 0.84 Proportion of Participants |
Secondary
Self-reported Contact With a Health Care Provider
Percentage of participant who self-reported contact with a health care provider within 90 days following an irregular pulse watch notification. Participants could self-report this health-care provider contact from 90 days following notification until the study survey went offline at end of study.
Time frame: 90 days to 15 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Apple Heart Study (AHS) App Users | Self-reported Contact With a Health Care Provider | 57 Percentage of participants |