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| Name | Class |
|---|---|
| University Hospital Birmingham | OTHER |
| University Hospital Southampton NHS Foundation Trust | OTHER |
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Atrial fibrillation (AF) is the most common arrhythmia (irregular heart rhythm), affecting 1-2 million people in the UK. AF significantly increases the risk of an AF-related stroke, heart failure and dementia. A significant proportion of people will have no symptoms, and they may only be found to have AF after suffering an AF-related stroke.
An electrocardiogram (ECG) uses sensors placed on the skin to record the heart's electrical activity. A 12-lead ECG uses 10 sensors and is the gold-standard (best available test) to detect any abnormal heart rhythm disturbances. Until recently, a 12-lead ECG showing an irregular heart rhythm was required to make a diagnosis of AF but as AF episodes are often short and unpredictable it may be missed. Therefore, a small device that continuously records heartbeat and heart rhythm could make the diagnosis of arrhythmias and AF much quicker and easier.
Accessories such as watches or rings - referred to as wearable devices - have extremely good sensors that measure pulse rate by detecting small changes in skin colour during each heartbeat and can perform a single-lead ECG. Algorithms built in the wearable devices can identify irregular heart rhythms, such as atrial fibrillation.
The purpose of this study is to test two new wearable devices - the Skylabs CART-I ring and the Apple Watch - in detecting abnormal heart rhythm recording and recording ECGs. The investigators plan to recruit 500 patients attending Cardiology Departments in several hospitals in the UK and will ask them to wear the Apple Watch and the CART-I and perform 12-lead ECG with each device (two in total). No extra follow-up visits are required. At the end of the study, the investigators will compare interpretation by two cardiologists of the wearable devices' ECGs and the 12-lead ECGs and look at their ability to automatically detect abnormal rhythms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion. Simultaneous 12-lead ECG and single-lead ECG with the SkyLabs CART-I ring followed by the Apple Watch. |
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| Group 2 | Experimental | The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion. Simultaneous 12-lead ECG and single-lead ECG with the Apple Watch followed by the SkyLabs CART-I ring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A | Device | Participants will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Skylab CART-I ring followed by Apple Watch. |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Diagnostic Performance of Physician Rhythm Interpretation of 1-lead ECG Generated by SkyLabs CART-I Ring and Apple Watch Versus 12-lead ECG (Gold-standard) for Atrial Fibrillation | Assessment of diagnostic accuracy of SkyLabs CART-I ring and Apple Watch 1-lead ECGs interpretation for for atrial fibrillaiton compared with a 12-lead ECG (gold-standard). | 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) | Assessment of diagnostic accuracy of the AF detection algorithm of the Skylab CART-I ring and Apple Watch compared to a 12-lead ECG (gold-standard). | 1 Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Betts, MD | Oxford University Hospitals NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Univeristy Hospitals NHS Foundation Trust | Oxford | Oxfordshire | OX89DU | United Kingdom | ||
| University Hospital Birmingham |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion. Simultaneous 12-lead ECG and single-lead ECG with the SkyLabs CART-I ring followed by the Apple Watch. Group A: Participants will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Skylab CART-I ring followed by Apple Watch. |
| FG001 | Group 2 | The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion. Simultaneous 12-lead ECG and single-lead ECG with the Apple Watch followed by the SkyLabs CART-I ring. Group B: they will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Apple Watch followed by the Skylab CART-I ring. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | The order in which the wearable devices being investigated will be randomly assigned in a 1:1 fashion. Simultaneous 12-lead ECG and single-lead ECG with the SkyLabs CART-I ring followed by the Apple Watch. Group A: Participants will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Skylab CART-I ring followed by Apple Watch. Group B: Participants will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Apple Watch followed by Apple Watch. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Compare the Diagnostic Performance of Physician Rhythm Interpretation of 1-lead ECG Generated by SkyLabs CART-I Ring and Apple Watch Versus 12-lead ECG (Gold-standard) for Atrial Fibrillation | Assessment of diagnostic accuracy of SkyLabs CART-I ring and Apple Watch 1-lead ECGs interpretation for for atrial fibrillaiton compared with a 12-lead ECG (gold-standard). | Diagnostic performance for Atrial Fibrillation | Posted | Number | 95% Confidence Interval | Percentage of cases | 1 Day | single-leads ECG | single-leads ECG |
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Duration of the study
Adverse events, including serious and non-serious adverse events, were actively monitored during the study period. No adverse events related to study procedures or devices were observed.Given the non-interventional design and brief exposure to wearable devices, no adverse events occurred during the 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 Watch | Participants using the Apple Watch | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Andre Briosa e Gala - EP Research Fellow | Oxford University Hospitals NHS Foundation Trust | 0300 304 7777 | andre.gala@uhs.nhs.uk |
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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 21, 2022 | May 28, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Group B | Device | they will be asked to perform a simultaneous 30-seconds 12-lead ECG and single-lead ECG for each wearable device: Apple Watch followed by the Skylab CART-I ring. |
|
| Compare the Accuracy of ECG Interval Measurement for the SkyLabs CART-I Ring and Apple Watch to a 12-lead ECG (Gold-standard) |
Level of agreement of measured interval duration between the SkyLabs CART-I ring, Apple Watch 1-lead ECG and a 12-lead ECG. |
| 1 Day |
| Compare the Accuracy of Heart Rate Detection of the SkyLabs CART-I Ring and Apple Watch 1-lead ECG to a 30-second 12-lead ECG | Correlation coefficient between the mean heart rate from simultaneous single lead and 12 lead ECG acquisitions. | 1 Day |
| Compare the Accuracy of Rhythm Interpretation of SkyLabs CART-I Ring 1-lead ECG to Combined PPG (Plethosysmography) Signal and 1-lead ECG. | Assessmen of diagnostic accuracy of the Skylab CART-I ring if a PPG signal is added. | 1 Day |
| Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) - Unclassified Excluded | Assessment of diagnostic accuracy of the AF detection algorithm of the Skylab CART-I ring and Apple Watch compared to a 12-lead ECG (gold-standard) with Unclassified SL-ECG were excluded | 1 Day |
| Birmingham |
| United Kingdom |
| University Hospital Southampton | Southampton | United Kingdom |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| BMI | Median | Inter-Quartile Range | Kg/m2 |
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| Ischaemic Heart Disease | Count of Participants | Participants |
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| Myocardial Infarction | Count of Participants | Participants |
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| Atrial Fibrillation | Count of Participants | Participants |
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| Atrial Tachycardia/Flutter | Count of Participants | Participants |
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| Congestive Cardiac Failure | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Valvular Heart Disease | Count of Participants | Participants |
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| Cardiac Surgery | Count of Participants | Participants |
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| CIED | Count of Participants | Participants |
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| CIED | Count of Participants | Participants |
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| Stroke/TIA | Count of Participants | Participants |
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| Secondary | Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) | Assessment of diagnostic accuracy of the AF detection algorithm of the Skylab CART-I ring and Apple Watch compared to a 12-lead ECG (gold-standard). | Posted | Number | 95% Confidence Interval | Perecenages of cases | 1 Day |
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| Secondary | Compare the Accuracy of ECG Interval Measurement for the SkyLabs CART-I Ring and Apple Watch to a 12-lead ECG (Gold-standard) | Level of agreement of measured interval duration between the SkyLabs CART-I ring, Apple Watch 1-lead ECG and a 12-lead ECG. | Not Posted | 1 Day | Participants |
| Secondary | Compare the Accuracy of Heart Rate Detection of the SkyLabs CART-I Ring and Apple Watch 1-lead ECG to a 30-second 12-lead ECG | Correlation coefficient between the mean heart rate from simultaneous single lead and 12 lead ECG acquisitions. | Not Posted | 1 Day | Participants |
| Secondary | Compare the Accuracy of Rhythm Interpretation of SkyLabs CART-I Ring 1-lead ECG to Combined PPG (Plethosysmography) Signal and 1-lead ECG. | Assessmen of diagnostic accuracy of the Skylab CART-I ring if a PPG signal is added. | Not Posted | 1 Day | Participants |
| Secondary | Compare the Accuracy of Automatic AF Detection of the SkyLabs CART-I Ring and Apple Watch Versus a Cardiologist Interpretation of a 12-lead ECG (Gold-standard) - Unclassified Excluded | Assessment of diagnostic accuracy of the AF detection algorithm of the Skylab CART-I ring and Apple Watch compared to a 12-lead ECG (gold-standard) with Unclassified SL-ECG were excluded | Posted | Number | 95% Confidence Interval | Percentage of cases | 1 Day |
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| 498 |
| 0 |
| 498 |
| 0 |
| 498 |
| EG001 | CART Ring | Participants using the CART Ring | 0 | 498 | 0 | 498 | 0 | 498 |
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