Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias (WEAR-TECH ECG)

  • STATUS
    Recruiting
  • End date
    Dec 1, 2023
  • participants needed
    500
  • sponsor
    Oxford University Hospitals NHS Trust
Updated on 11 May 2022
electrocardiogram
stroke
heart failure
arrhythmia
fibrillation
a 12
12 lead ECG
Accepts healthy volunteers

Summary

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.

Details
Condition Cardiac Arrhythmia, Atrial Fibrillation
Treatment Group A, Group B
Clinical Study IdentifierNCT05298553
SponsorOxford University Hospitals NHS Trust
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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