Trial Outcomes & Findings for Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias (NCT NCT03335800)
NCT ID: NCT03335800
Last Updated: 2020-03-30
Results Overview
Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
419927 participants
Primary outcome timeframe
During ambulatory ECG monitoring (up to 8 days)
Results posted on
2020-03-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
419927
|
|
Overall Study
Received Irregular Pulse Notification
|
2161
|
|
Overall Study
Attended First Study Visit
|
945
|
|
Overall Study
ECG Patch Shipped
|
658
|
|
Overall Study
ECG Patch Returned for Analysis
|
450
|
|
Overall Study
Attended Second Study Visit
|
396
|
|
Overall Study
COMPLETED
|
396
|
|
Overall Study
NOT COMPLETED
|
419531
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
Baseline characteristics by cohort
| Measure |
Apple Heart Study (AHS) App Users
n=419927 Participants
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
|
|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
177087 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
238700 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Other
|
396 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Not Reported
|
3114 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
286190 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
48775 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
32275 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26156 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
4696 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
1493 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
3652 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other or mixed race
|
7958 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
8102 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
419927 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During ambulatory ECG monitoring (up to 8 days)Population: Participant who returned ECG Patch
Proportion of notified participants who received an irregular pulse notification and that had AF detected on the ambulatory ECG.
Outcome measures
| Measure |
Apple Heart Study (AHS) App Users
n=450 Participants
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
|
|---|---|
|
Atrial Fibrillation (AF) of Greater Than 30 Seconds
|
0.34 Proportion of participants
Interval 0.29 to 0.39
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Apple Heart Study (AHS) App Users
n=2089 Tachograms
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
|
|---|---|
|
Confirmed AF With a Detection by a Component of the App
|
0.71 Proportion of Tachograms with AF
Interval 0.69 to 0.74
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Apple Heart Study (AHS) App Users
n=86 Participants
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
|
|---|---|
|
Concordant AF With App Algorithm Notification
|
0.84 Proportion of Participants
Interval 0.76 to 0.92
|
SECONDARY outcome
Timeframe: 90 days to 15 monthsPercentage 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.
Outcome measures
| Measure |
Apple Heart Study (AHS) App Users
n=1376 Participants
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
|
|---|---|
|
Self-reported Contact With a Health Care Provider
|
57 Percentage of participants
Interval 54.0 to 60.0
|
Adverse Events
Apple Heart Study (AHS) App Users
Serious events: 62 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Apple Heart Study (AHS) App Users
n=419927 participants at risk
Participants used the AHS App to detect episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
|
|---|---|
|
Immune system disorders
Allergic reaction
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Atrial Fibrilation
|
0.01%
40/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect diagnosed
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Chest Pain
|
0.00%
3/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
General disorders
Chest Pain
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Death
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
General disorders
Drug Reaction
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
General disorders
Fall
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Increased frequency of Premature Ventricular Contractions (PVC)
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Left bundle branch block
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Mitral regurgitation
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Mitral Valve Disease
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Palpitations
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
2/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Infections and infestations
Pneumonia
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Surgical and medical procedures
Procedural Complication
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Shortness of Breath
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Infections and infestations
Shortness of breath
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Shortness of Breath
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Vascular disorders
Stroke
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Vascular disorders
Subdural hematoma
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Cardiac disorders
Syncope
|
0.00%
3/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
|
Injury, poisoning and procedural complications
Trauma
|
0.00%
1/419927 • 1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
|
Other adverse events
Adverse event data not reported
Additional Information
Minang (Mintu) Turakhia, Associate Professor of Medicine, Stanford University
Associate Professor of Medicine, Stanford University
Phone: (650) 493-5000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place