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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Apple Heart Study App | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apple Heart Study App | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | During ambulatory ECG monitoring (up to 8 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During ambulatory ECG monitoring (up to 8 days) |
| Self-reported Contact With a Health Care Provider |
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Inclusion Criteria:
Possession of the following at time of eligibility screening, ascertained from automatic hardware/software/device pairing check:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minang (Mintu) Turakhia, MD, MAS | Stanford University | Principal Investigator |
| Marco V. Perez, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94304 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40673279 | Derived | Nguyen KT, Yu J, Hedlin H, Phillips AT, Desai S, Cheung L, Kowey PR, Jain SS, Rumsfeld JS, Russo AM, Granger CB, Hills MT, Desai M, Mahaffey KW, Turakhia MP, Perez MV. Racial and Ethnic Representation and Study Engagement in a Siteless Digital Clinical Trial Using a Smartwatch: Findings From the Apple Heart Study. Mayo Clin Proc Digit Health. 2025 Jun 3;3(3):100232. doi: 10.1016/j.mcpdig.2025.100232. eCollection 2025 Sep. | |
| 35695137 |
| Label | URL |
|---|---|
| Website for study information | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participant who returned ECG Patch | Posted | Number | 97.5% Confidence Interval | Proportion of participants | During ambulatory ECG monitoring (up to 8 days) |
|
|
1 year, 2 months and 14 days (participants may have reported adverse events at any time from enrollment to close of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Minang (Mintu) Turakhia, Associate Professor of Medicine, Stanford University | Associate Professor of Medicine, Stanford University | (650) 493-5000 | mintu@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2018 | Feb 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D001145 | Arrhythmias, Cardiac |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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. |
| 90 days to 15 months |
| Derived |
| Garcia A, Balasubramanian V, Lee J, Gardner R, Gummidipundi S, Hung G, Ferris T, Cheung L, Granger C, Kowey P, Rumsfeld J, Russo A, Hills MT, Talati N, Nag D, Stein J, Tsay D, Desai S, Mahaffey K, Turakhia M, Perez M, Hedlin H, Desai M. Lessons learned in the Apple Heart Study and implications for the data management of future digital clinical trials. J Biopharm Stat. 2022 May 4;32(3):496-510. doi: 10.1080/10543406.2022.2080698. Epub 2022 Jun 12. |
| 31722151 | Derived | Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183. |
| 30392584 | Derived | Turakhia MP, Desai M, Hedlin H, Rajmane A, Talati N, Ferris T, Desai S, Nag D, Patel M, Kowey P, Rumsfeld JS, Russo AM, Hills MT, Granger CB, Mahaffey KW, Perez MV. Rationale and design of a large-scale, app-based study to identify cardiac arrhythmias using a smartwatch: The Apple Heart Study. Am Heart J. 2019 Jan;207:66-75. doi: 10.1016/j.ahj.2018.09.002. Epub 2018 Sep 8. |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | 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. | Posted | Number | 97.5% Confidence Interval | Proportion of Tachograms with AF | During ambulatory ECG monitoring (up to 8 days) | Tachograms | Tachograms |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Proportion of Participants | During ambulatory ECG monitoring (up to 8 days) |
|
|
|
| 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 90 days to 15 months |
|
|
|
| 2 |
| 419,927 |
| 62 |
| 419,927 |
| 0 |
| 419,927 |
| Atrial Fibrilation | Cardiac disorders | Non-systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | Non-systematic Assessment |
|
| Atrial Septal Defect diagnosed | Congenital, familial and genetic disorders | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Chest Pain | General disorders | Non-systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | Non-systematic Assessment |
|
| Death | Cardiac disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Drug Reaction | General disorders | Non-systematic Assessment |
|
| Fall | General disorders | Non-systematic Assessment |
|
| Increased frequency of Premature Ventricular Contractions (PVC) | Cardiac disorders | Non-systematic Assessment |
|
| Left bundle branch block | Cardiac disorders | Non-systematic Assessment |
|
| Mitral regurgitation | Cardiac disorders | Non-systematic Assessment |
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| Mitral Valve Disease | Cardiac disorders | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | Non-systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Procedural Complication | Surgical and medical procedures | Non-systematic Assessment |
|
| Shortness of Breath | Cardiac disorders | Non-systematic Assessment |
|
| Shortness of breath | Infections and infestations | Non-systematic Assessment |
|
| Shortness of Breath | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Stroke | Vascular disorders | Non-systematic Assessment |
|
| Subdural hematoma | Vascular disorders | Non-systematic Assessment |
|
| Syncope | Cardiac disorders | Non-systematic Assessment |
|
| Trauma | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
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