Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias

Study Overview
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Brief Summary
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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.

Official Title
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Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias: WEAR-TECH ECG

Conditions
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Cardiac Arrhythmia, Atrial Fibrillation

Intervention / Treatment
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* Device: Group A
* Device: Group B


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the trial. Male or female aged 18 years or above. Indication for 12-lead ECG. Exclusion Criteria: Unable to comply with instructions. Tattoos in the wrists or fingers where the device will be placed. Severe skin allergy to silicone (Apple Watch wrist band) or nickel allergies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>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. | Device: Group A<br>* 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.<br>|
| Experimental: Group 2<br>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. | Device: Group B<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the accuracy of physician rhythm interpretation of 1-lead ECG generated by SkyLabs CART-I ring and Apple Watch versus 12-lead ECG (gold-standard) | Assessment of diagnostic accuracy of SkyLabs CART-I ring and Apple Watch 1-lead ECGs interpretation for different cardiac arrhythmias (atrial compared with a 12-lead ECG (gold-standard). | 1 Day | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apple Watch;, Skylabs CART-I Ring, Wearable Devices