BENITIONSClinical Trial Intelligence

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

N/A Completed NCT05298553

ConditionCardiac Arrhythmia, Atrial Fibrillation
PhaseN/A
SponsorOxford University Hospitals NHS Trust
StatusCompleted
Enrollment500 participants
InterventionsGroup A, Group B
Start dateApr 18, 2022
Completion dateApr 1, 2023
Results postedJun 1, 2026

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,

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

1 Day · Percentage of cases

Apple Watch95.4 Percentage of cases
CART Ring94.3 Percentage of cases
Apple Watch89.8 Percentage of cases
CART Ring88.8 Percentage of cases
Apple Watch85.6 Percentage of cases
CART Ring84.3 Percentage of cases

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