An interventional study of Apple Heart Study App in Atrial Fibrillation, Arrhythmias, Cardiac and Atrial Flutter, sponsored by Apple Inc.. Completed at 1 site in United States. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Apple Inc. · Not applicable, Interventional, and Screening
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.
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's enrollment of 419,927 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Apple Inc. is the lead sponsor of 12 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:
Exclusion Criteria:
Device: Apple 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.
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)
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)
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)
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
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.
| Milestone | Apple Heart Study (AHS) App Users |
|---|---|
| Started | 419927 |
| Received irregular pulse notification | 2161 |
| Attended first study visit | 945 |
| Ecg patch shipped | 658 |
| Ecg patch returned for analysis | 450 |
| Attended second study visit | 396 |
| Completed | 396 |
| Not completed | 419531 |
Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.
| Proportion of participants | Apple Heart Study (AHS) App Users |
|---|---|
| Atrial Fibrillation (AF) of Greater Than 30 Seconds | 0.34 (0.29 to 0.39) |
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.
| Proportion of Tachograms with AF | Apple Heart Study (AHS) App Users |
|---|---|
| Confirmed AF With a Detection by a Component of the App | 0.71 (0.69 to 0.74) |
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.
| Proportion of Participants | Apple Heart Study (AHS) App Users |
|---|---|
| Concordant AF With App Algorithm Notification | 0.84 (0.76 to 0.92) |
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.
| Percentage of participants | Apple Heart Study (AHS) App Users |
|---|---|
| Self-reported Contact With a Health Care Provider | 57 (54 to 60) |
Collected over 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Apple Heart Study (AHS) App Users | 2/419,927 (0%) | 62/419,927 (0%) | 0/419,927 (0%) |
| Event | Apple Heart Study (AHS) App Users |
|---|---|
| Atrial FibrilationCardiac disorders | 40/419927 |
| Chest PainCardiac disorders | 3/419927 |
| SyncopeCardiac disorders | 3/419927 |
| PancreatitisGastrointestinal disorders | 2/419927 |
| Allergic reactionImmune system disorders | 1/419927 |
| Atrial FlutterCardiac disorders | 1/419927 |
| Atrial Septal Defect diagnosedCongenital, familial and genetic disorders | 1/419927 |
| Chest PainGeneral disorders | 1/419927 |
| Coronary Artery DiseaseCardiac disorders | 1/419927 |
| DeathCardiac disorders | 1/419927 |
| Age, Continuous(years) | Apple Heart Study (AHS) App Users |
|---|---|
| Mean | 41 ± 13 |
| Sex/Gender, Customized(Participants) | Apple Heart Study (AHS) App Users |
|---|---|
| Female | 177087 |
| Male | 238700 |
| Other | 396 |
| Not Reported | 3114 |
| Race/Ethnicity, Customized(Participants) | Apple Heart Study (AHS) App Users |
|---|---|
| White | 286190 |
| Hispanic | 48775 |
| Black | 32275 |
| Asian | 26156 |
| American Indian | 4696 |
| Pacific Islander | 1493 |
| Middle Eastern | 3652 |
| Other or mixed race | 7958 |
| Not Reported | 8102 |
| Region of Enrollment(Participants) | Apple Heart Study (AHS) App Users |
|---|---|
| United States | 419927 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2017 to primary completion in Feb 2019, 14 months.
Results were first posted in Mar 2020, 1 year 1 month after primary completion.
Of 255 industry-sponsored interventional studies with no phase under Atrial Fibrillation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 14 months is below that.
Counting every sponsor, half of 1,051 studies reached it within 33 months; a quarter within 18 and three quarters within 54.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Apple Inc.