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N/A N=498 Randomized Single-blind Diagnostic

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

Cardiac Arrhythmia · Atrial Fibrillation

Enrolled (actual)
498
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcome: 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 — 95.4; 94.3; 89.8; 88.8 Percentage of cases

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Group A (Device); Group B (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Oxford University Hospitals NHS Trust
Primary completion
Apr 2023

Outcome Measures

OutcomeResultp-value
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
95.4; 94.3; 89.8; 88.8; 85.6; 84.3
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)
69.1; 84.6; 70.7; 89.4; 60.1; 83.8
SECONDARY
Compare the Accuracy of ECG Interval Measurement for the SkyLabs CART-I Ring and Apple Watch to a 12-lead ECG (Gold-standard)
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
SECONDARY
Compare the Accuracy of Rhythm Interpretation of SkyLabs CART-I Ring 1-lead ECG to Combined PPG (Plethosysmography) Signal and 1-lead ECG.
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
84.8; 86.4; 92.9; 88.9; 88.7; 83.3

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05298553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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