Atrial Fibrillation, Cardiac Arrhythmia
Conditions
Keywords
Apple Watch;, Skylabs CART-I Ring, Wearable Devices
Brief 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.
Interventions
DEVICEGroup 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.
DEVICEGroup 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.
Sponsors
Oxford University Hospitals NHS Trust
University Hospital Birmingham
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 1 Day | 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). |
| Compare the Accuracy of ECG Interval Measurement for the SkyLabs CART-I Ring and Apple Watch to a 12-lead ECG (Gold-standard) | 1 Day | Level of agreement of measured interval duration between the SkyLabs CART-I ring, Apple Watch 1-lead ECG and a 12-lead ECG. |
| 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 | 1 Day | Correlation coefficient between the mean heart rate from simultaneous single lead and 12 lead ECG acquisitions. |
| Compare the Accuracy of Rhythm Interpretation of SkyLabs CART-I Ring 1-lead ECG to Combined PPG (Plethosysmography) Signal and 1-lead ECG. | 1 Day | Assessmen of diagnostic accuracy of the Skylab CART-I ring if a PPG signal is added. |
| 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 | 1 Day | 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 |
Countries
United Kingdom
Contacts
PRINCIPAL_INVESTIGATORTim Betts, MD
Oxford University Hospitals NHS Trust
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66 years |
| Atrial Fibrillation | 303 Participants |
| Atrial Tachycardia/Flutter | 59 Participants |
| BMI | 27.8 Kg/m2 |
| Cardiac Surgery | 59 Participants |
| CIED | 47 Participants |
| Congestive Cardiac Failure | 109 Participants |
| Hypertension | 156 Participants |
| Ischaemic Heart Disease | 113 Participants |
| Myocardial Infarction | 68 Participants |
| Sex: Female, Male Female | 142 Participants |
| Sex: Female, Male Male | 356 Participants |
| Stroke/TIA | 30 Participants |
| Valvular Heart Disease | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 498 | 0 / 498 |
| other Total, other adverse events | 0 / 498 | 0 / 498 |
| serious Total, serious adverse events | 0 / 498 | 0 / 498 |
Outcome results
None listed