Cardiac ArrhythmiaWEAR-TECH ECGNCT05298553
Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias
A study testing Group A and Group B in people with Cardiac Arrhythmia and Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia, Atrial Fibrillation
- What is being tested?
- Group A and Group B
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 18 Apr 2022to 1 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
University Hospital Birmingham
Birmingham
Oxford Univeristy Hospitals NHS Foundation Trust
Oxford, Oxfordshire, OX89DU
University Hospital Southampton
Southampton
About this study
Official title: 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.
Read more
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.
- Conditions
- Cardiac Arrhythmia, Atrial Fibrillation
- Being tested
- Group A, Group B
- Keywords
- Apple Watch;, Skylabs CART-I Ring, Wearable Devices
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group ADevice
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.
Group BDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Device: Group A |
| Group 2 | Experimental | 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. Receives: Device: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 Day
Secondary outcomes (5)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start18 Apr 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Birmingham, University Hospital Southampton NHS Foundation Trust
- Responsible party
- Principal investigator, Tim Betts MD MBChB FRCP, Oxford University Hospitals NHS Trust
- Investigators
- Tim Betts, MD, Principal investigator, Oxford University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298553
- Sponsor's protocol ID
- 15487
- Acronym
- WEAR-TECH ECG
- Status last verified
- May 2026
- First submitted
- 12 Dec 2021
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias: WEAR-TECH ECG
- ClinicalTrials.gov ID
- NCT05298553
- Acronym / sponsor ID
- WEAR-TECH ECG / 15487
- Conditions
- Cardiac Arrhythmia, Atrial Fibrillation
- Keywords
- Apple Watch;, Skylabs CART-I Ring, Wearable Devices
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Collaborators
- University Hospital Birmingham, University Hospital Southampton NHS Foundation Trust
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 28 Mar 2022 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Group AThe 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. |
| Group 2 | Experimental | Device: Group BThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group AParticipants 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. | Device | Group 1 |
| Group Bthey 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. | Device | Group 2 |
Primary outcome
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
Time frame: 1 Day
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).
5 secondary outcomes
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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 1 Day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tim Betts, MD principal investigator
Oxford University Hospitals NHS Trust
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Cardiac Arrhythmia and Atrial Fibrillation, run by Oxford University Hospitals NHS Trust at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.