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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Cardiac Arrhythmia
• Intervention / Treatment: Device: Group A; Device: Group B

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • University Hospital Birmingham
  • Southampton, United Kingdom
    • University Hospital Southampton
  • Oxfordshire
    • Oxford, Oxfordshire, United Kingdom, OX89DU
      • Oxford Univeristy Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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
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

Collaborators and Investigators

• Sponsor: Oxford University Hospitals NHS Trust
• Collaborators: University Hospital Southampton NHS Foundation Trust; University Hospital Birmingham
• Investigators: Principal Investigator: Tim Betts, MD, Oxford University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: March 25, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Wearable Devices; Apple Watch;; Skylabs CART-I Ring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Arrhythmias, Cardiac
• Other Study ID Numbers: 15487

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No