Smartwatch irregular-pulse detection
Watches and similar worn devices can check the pulse with light sensors and flag a pulse pattern that may be atrial fibrillation. A flag is a prompt to get checked, not a diagnosis. In the Apple Heart Study, only 2161 of 419,297 participants received an alert, and 34% of those who returned an analyzable ECG patch had atrial fibrillation on it.
Also called Wearable rhythm detection · Smartwatch rhythm detection
- Technology
- In this atlas
Overview
Technical summary
Photoplethysmography on wearable devices. The Apple Heart Study abstract says optical sensors on wearable devices can detect irregular pulses. In that study a smartwatch algorithm flagged a possible irregular pulse, which started a telemedicine visit and a mailed ECG patch. FDA's device-type name for De Novo product code QDB is photoplethysmograph analysis software for over-the-counter use. The study measured agreement between alerts and an ECG patch. It did not measure stroke or other clinical outcomes. Other detection devices, such as handheld or phone-case ECG sensors, are not covered here.
How it works
A light sensor on a worn device reads the pulse. Software looks for an irregular pattern and, if it finds one, sends a notification. A possible finding is then checked with an ECG.
Strengths
- It runs on a device that people already wear. The Apple Heart Study needed no on-site visits (the paper calls the design siteless), so it could recruit 419,297 participants over 8 months.
- The paper reports no serious app-related adverse events in the study.
Limitations
- 34% of notified participants who returned an analyzable ECG patch had atrial fibrillation on it (97.5% confidence interval 29 to 39). The patches were applied on average 13 days after the notification.
- Only 450 of the 2161 notified participants returned analyzable patches.
- Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study, so alerts can lead to follow-up visits.
- The study measured agreement with an ECG patch. The registry lists no stroke or other clinical outcome.
Required infrastructure
- A compatible smartwatch paired with a smartphone. The Apple Heart Study required an iPhone 5s or later with iOS 11.0 or later and an Apple Watch Series 1 or later with watchOS 4.0 or later.
- A way to confirm a possible finding with an ECG. The study started a telemedicine visit and mailed an ECG patch to wear for up to 7 days.
Claims and evidence
Context US adults with a compatible iPhone and Apple Watch and no self-reported atrial fibrillation (Apple Heart Study)
- Recipient
- Adult
- Population
- People aged 22 or older who lived in the United States, owned a compatible iPhone and Apple Watch, had no self-reported diagnosis of atrial fibrillation or atrial flutter, and were not on anticoagulation therapy (registry exclusion criteria).
- Care setting
- Remote and siteless. People consented and took part through a smartphone app with no on-site visits. After a notification, the study started a telemedicine visit and mailed an ECG patch to the participant.
- Geography
- United States (the registry lists only the United States as a country)
- Life stage
- Adults aged 22 or older (registry minimum age). The abstract reports one result separately for participants aged 65 or older.
- Follow-up
- Median of 117 days of monitoring. An ECG patch was worn for up to 7 days (the registry gives up to 8 days of ambulatory monitoring) and was applied on average 13 days after a notification. Surveys were sent 90 days after a notification and at the end of the study.
Eligibility: 4 inclusion criteria; 3 exclusion criteria
- Included
- Age 22 years or older (registry minimum age)
- Current resident of the United States
- A compatible iPhone (5s or later, iOS 11.0 or later) and Apple Watch (Series 1 or later, watchOS 4.0 or later)
- Proficient in written and spoken English, a valid phone number and a valid email address (registry)
- Excluded
- Self-reported diagnosis of atrial fibrillation
- Self-reported diagnosis of atrial flutter
- Currently on anticoagulation therapy
In the Apple Heart Study, 419,297 participants with no self-reported atrial fibrillation used an Apple Watch and iPhone app, and were followed for a median of 117 days. 2161 of them (0.52%) received a notification of an irregular pulse. Of the 450 notified participants who returned ECG patches with data that could be analyzed (applied on average 13 days after the notification), 34% had atrial fibrillation on the patch (97.5% confidence interval 29 to 39), and 35% of those aged 65 or older (97.5% CI 27 to 43). Separately, the positive predictive value among notified participants was 0.84 (95% CI 0.76 to 0.92) for atrial fibrillation on the ECG at the same time as a later irregular pulse notification, and 0.71 (97.5% CI 0.69 to 0.74) for atrial fibrillation on the ECG at the same time as an irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. The paper reports no serious app-related adverse events.
Applies to Adult- People aged 22 or older who lived in the United States, owned a compatible iPhone and Apple Watch, had no self-reported diagnosis of atrial fibrillation or atrial flutter, and were not on anticoagulation therapy (registry exclusion criteria).
- Remote and siteless. People consented and took part through a smartphone app with no on-site visits. After a notification, the study started a telemedicine visit and mailed an ECG patch to the participant.
- United States (the registry lists only the United States as a country)
- Adults aged 22 or older (registry minimum age). The abstract reports one result separately for participants aged 65 or older.
- Certainty method
- Not assessed
- Limitations
- Single-group study with no comparison group, using the study's own research app. The result is not about the FDA-authorized feature itself, and the sources read do not say how the two relate. The registry lists as outcomes the share of notified participants with AF on the ECG, agreement between the app and the ECG, and contact with a health care provider. It lists no stroke or other clinical outcome, so the study does not show that notifications prevent strokes. Only 450 of the 2161 notified participants returned analyzable patches. The abstract gives the 34% (97.5% CI) and the 0.84 (95% CI) as separate measures, and they are not the same quantity. The registry enrollment (419927) and the abstract recruitment count (419,297) differ and are not reconciled. Participants were self-selected owners of a compatible phone and watch, and the abstract does not describe their health or demographics. Abstract only; the PMC copy is not in the Open Access subset and the full text was not read.
- Last checked
- 2026-10-14
- Next evidence check due
- Not scheduled
Sources and citations (17)
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 1
- How it applies
- Recruitment count.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 2
- How it applies
- Median monitoring and notification count.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 1
- How it applies
- Patch count and timing (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 2
- How it applies
- Share with AF on the patch (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 3, fragment 3
- How it applies
- Share aged 65 or older (third fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 4, fragment 1
- How it applies
- Positive predictive value for the notification (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 4, fragment 2
- How it applies
- Positive predictive values for the notification and the tachogram (second fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 4, fragment 3
- How it applies
- Tachogram measure (third fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 5
- How it applies
- Contact with providers after a notification.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, RESULTS, sentence 6
- How it applies
- No serious app-related adverse events reported.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, CONCLUSIONS, sentence 1
- How it applies
- The authors' own summary: the chance of a notification was low.
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
Background Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Locator
- Abstract, METHODS, sentence 4, fragment 1
- How it applies
- Main objectives of the study (first fragment).
- Retrieved
- Source effective date
- Not reported
- Source state
- Current
- Snapshot hash
3a30de5458d89e92e2f2f19442f726ff4149eb0abd8ff3ce4e0cd88072ec4315- Reuse basis
- PubMed record fetched through NCBI E-utilities (label cf-pubmed-31722151.xml). Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.
-
- Locator
- protocolSection.outcomesModule.primaryOutcomes[0].measure
- How it applies
- Registry primary outcome 1.
- Retrieved
- Source effective date
- 2020-03-30
- Source state
- Current
- Snapshot hash
d32097cfe2767d4a1fb8337dbd9bf84990d1608aae0e10402628075e51c296ba- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT03335800.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
-
- Locator
- protocolSection.outcomesModule.primaryOutcomes[1].measure
- How it applies
- Registry primary outcome 2.
- Retrieved
- Source effective date
- 2020-03-30
- Source state
- Current
- Snapshot hash
d32097cfe2767d4a1fb8337dbd9bf84990d1608aae0e10402628075e51c296ba- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT03335800.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
-
- Locator
- protocolSection.outcomesModule.secondaryOutcomes[0].measure
- How it applies
- Registry secondary outcome 1.
- Retrieved
- Source effective date
- 2020-03-30
- Source state
- Current
- Snapshot hash
d32097cfe2767d4a1fb8337dbd9bf84990d1608aae0e10402628075e51c296ba- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT03335800.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
-
- Locator
- protocolSection.outcomesModule.secondaryOutcomes[1].measure
- How it applies
- Registry secondary outcome 2.
- Retrieved
- Source effective date
- 2020-03-30
- Source state
- Current
- Snapshot hash
d32097cfe2767d4a1fb8337dbd9bf84990d1608aae0e10402628075e51c296ba- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT03335800.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
-
- Locator
- protocolSection.designModule.enrollmentInfo.count
- How it applies
- Registry enrollment count, which differs from the abstract.
- Retrieved
- Source effective date
- 2020-03-30
- Source state
- Current
- Snapshot hash
d32097cfe2767d4a1fb8337dbd9bf84990d1608aae0e10402628075e51c296ba- Reuse basis
- Registry record. The raw API JSON is committed at research/snapshots/cf-ctgov-NCT03335800.json. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read, so the redistribution basis is unverified. Public text is quote, following Ben's decision of 2026-10-13 (medical-atlas-core issue 2) that registries allow short quotations with attribution. Any quotation stays short.
Clinical links
Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.
-
Claim, not a settled fact Alerts compared with an ECG patch in the Apple Heart Study: Atrial fibrillation (AF)
Applies to Adult- People aged 22 or older who lived in the United States, owned a compatible iPhone and Apple Watch, had no self-reported diagnosis of atrial fibrillation or atrial flutter, and were not on anticoagulation therapy (registry exclusion criteria).
- Remote and siteless. People consented and took part through a smartphone app with no on-site visits. After a notification, the study started a telemedicine visit and mailed an ECG patch to the participant.
- United States (the registry lists only the United States as a country)
- Adults aged 22 or older (registry minimum age). The abstract reports one result separately for participants aged 65 or older.
In the Apple Heart Study, 419,297 participants with no self-reported atrial fibrillation used an Apple Watch and iPhone app, and were followed for a median of 117 days. 2161 of them (0.52%) received a notification of an irregular pulse. Of the 450 notified participants who returned ECG patches with data that could be analyzed (applied on average 13 days after the notification), 34% had atrial fibrillation on the patch (97.5% confidence interval 29 to 39), and 35% of those aged 65 or older (97.5% CI 27 to 43). Separately, the positive predictive value among notified participants was 0.84 (95% CI 0.76 to 0.92) for atrial fibrillation on the ECG at the same time as a later irregular pulse notification, and 0.71 (97.5% CI 0.69 to 0.74) for atrial fibrillation on the ECG at the same time as an irregular tachogram. Of 1376 notified participants who returned a 90-day survey, 57% contacted health care providers outside the study. The paper reports no serious app-related adverse events.Limitations. Single-group study with no comparison group, using the study's own research app. The result is not about the FDA-authorized feature itself, and the sources read do not say how the two relate. The registry lists as outcomes the share of notified participants with AF on the ECG, agreement between the app and the ECG, and contact with a health care provider. It lists no stroke or other clinical outcome, so the study does not show that notifications prevent strokes. Only 450 of the 2161 notified participants returned analyzable patches. The abstract gives the 34% (97.5% CI) and the 0.84 (95% CI) as separate measures, and they are not the same quantity. The registry enrollment (419927) and the abstract recruitment count (419,297) differ and are not reconciled. Participants were self-selected owners of a compatible phone and watch, and the abstract does not describe their health or demographics. Abstract only; the PMC copy is not in the Open Access subset and the full text was not read.
Record details
- Record id
cardio:wearable-rhythm-detection- Content hash
bf90005254096a38b0e7504e4928cf95301cdf20d40ac2c3e98b0ba8a862fed5