Clinical trial NCT05298553: Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias
Official title: Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias: WEAR-TECH ECG
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrhythmia
Atrial Fibrillation
Keywords: Apple Watch;
Skylabs CART-I Ring
Wearable Devices
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: University Hospital Birmingham
name: University Hospital Southampton NHS Foundation Trust
First posted: 2022-03-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: Compare the accuracy of physician rhythm interpretation of 1-lead ECG generated by SkyLabs CART-I ring and Apple Watch versus 12-lead ECG (gold-standard)
timeFrame: 1 Day
Secondary outcomes:
measure: 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)
timeFrame: 1 Day
measure: Compare the accuracy of ECG interval measurement for the SkyLabs CART-I Ring and Apple Watch to a 12-lead ECG (gold-standard)
timeFrame: 1 Day
measure: 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
timeFrame: 1 Day
measure: Compare the accuracy of rhythm interpretation of SkyLabs CART-I ring 1-lead ECG to combined PPG (plethosysmography) signal and 1-lead ECG.
timeFrame: 1 Day
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Univeristy Hospitals NHS Foundation Trust
state: Oxfordshire
city: Birmingham
country: United Kingdom
facility: University Hospital Birmingham
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
Study officials:
affiliation: Oxford University Hospitals NHS Trust
name: Tim Betts, MD
role: PRINCIPAL_INVESTIGATOR
References: