Atrial FibrillationNCT03335800
Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
A study testing Apple Heart Study App in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Apple Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
- What is being tested?
- Apple Heart Study App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 419,927 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 21 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Self-reported diagnosis of Atrial Fibrillation.
- Self-reported diagnosis of Atrial Flutter.
- Currently on anti-coagulation therapy.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
- Being tested
- Apple Heart Study App
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apple Heart Study AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Apple Heart Study App | Experimental | Not described Receives: Device: Apple Heart Study App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During ambulatory ECG monitoring (up to 8 days)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 90 days to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start29 Nov 2017
- Primary completion21 Feb 2019
- Study completion21 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 419,927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apple Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Principal investigator, Minang (Mintu) Turakhia, Stanford University
- Investigators
- Minang (Mintu) Turakhia, MD, MAS, Principal investigator, Stanford UniversityMarco V. Perez, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335800
- Sponsor's protocol ID
- 1.0
- Status last verified
- Mar 2020
- First submitted
- 2 Nov 2017
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40673279Garcia 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.
PubMed 35695137Perez 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.
PubMed 31722151Turakhia 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.
PubMed 30392584
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT03335800
- Acronym / sponsor ID
- 1.0
- Conditions
- Atrial Fibrillation, Arrhythmias, Cardiac, Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 419,927 participants (actual)
- Lead sponsor
- Apple Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 21 Feb 2019 (actual)
- Study completion
- 21 Feb 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apple Heart Study App | Experimental | Device: Apple Heart Study App |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- Self-reported diagnosis of Atrial Fibrillation.
- Self-reported diagnosis of Atrial Flutter.
- Currently on anti-coagulation therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apple Heart Study AppThe 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. | Device | Apple Heart Study App |
Primary outcome
Atrial Fibrillation (AF) of Greater Than 30 Seconds
Time frame: 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
Time frame: 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.
2 secondary outcomes
Concordant AF With App Algorithm Notification
Time frame: During ambulatory ECG monitoring (up to 8 days)
Self-reported Contact With a Health Care Provider
Time frame: 90 days to 15 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40673279Nguyen 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.
- Derived from this study: PubMed 35695137Garcia 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.
- Derived from this study: PubMed 31722151Perez 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.
- Derived from this study: PubMed 30392584Turakhia 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.
- Website for study informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minang (Mintu) Turakhia, MD, MAS principal investigator
Stanford University
Marco V. Perez, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple Heart Study App in people with Atrial Fibrillation and Arrhythmias, Cardiac, run by Apple Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Atrial Fibrillation (AF) of Greater Than 30 Seconds (time frame: During ambulatory ECG monitoring (up to 8 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03335800, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.