Remote paediatric ECG monitoring with the AliveCor KardiaMobile 6L
Research type
Research Study
Full title
A validation study for the use of the AliveCor KardiaMobile 6L device for remote ECG monitoring in children diagnosed with hypertrophic cardiomyopathy and long QT syndrome
IRAS ID
284257
Contact name
Juan Pablo Kaski
Contact email
Sponsor organisation
Great Ormond Street Hopital for Children NHS Foundation Trust
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Research Summary
This study aims to validate use of the AliveCor KardiaMobile 6L device in children (up to 18 years old) diagnosed with hypertrophic cardiomyopathy and long QT syndrome. The device is capable of producing a 6-lead resting ECG reading in patients outside the healthcare setting. It is activated by touch and transmits ECG readings via an app on the user’s mobile device directly to the patient’s cardiologist. This remote monitoring capability limits the need for patients to attend hospital in person, which is beneficial during the current Covid-19 pandemic and potentially in the longer term, as we seek new ways to monitor and triage our patients in the future.
The KardiaMobile 6L is the only monitor of its type which can be used for accurate calculation of the QT interval. This ECG parameter indicates the time taken by the heart to electrically “reset” after each beat. QT interval can be prolonged in patients with certain heart conditions (such as long QT syndrome and hypertrophic cardiomyopathy), increasing their risk of life-threatening arrhythmias. Careful monitoring of the QT interval in these patients is therefore of critical importance. Although validated in adults previously, the KardiaMobile 6L device requires validation in children.
At routine clinic visits (following informed consent), enrolled patients will be asked to measure their ECG using the KardiaMobile device. A standard 12-lead ECG will also be carried out. Patients will then take the KardiaMobile device home with them for three months and will send 6-lead ECGs at monthly intervals or whenever they experience cardiac symptoms. Devices will then be returned to the study team by pre-paid post.
By comparing standard 12-lead ECGs with ECGs recorded using the AliveCor deivce, we aim to establish the safety, accuracy and potential utility of this device as a diagnostic tool in this patient population.Summary of Results
64 children were recruited to the study (22 diagnosed with hypertrophic cardiomyopathy [HCM], 22 diagnosed with long QT syndrome [LQTS] and 20 controls). The children underwent standard 12-lead ECGs in the outpatient clinic, and they also undertook an ECG recording using the KardiaMobile 6L device while in the clinic following teaching from a member of the study team. Patients then took the KardiaMobile devices home and sent monthly ECG recordings from home for a three month period before returning the devices. In children diagnosed with HCM, ECG abnormalities in the limb leads on the 12-lead ECG were reliably reproduced by the KardiaMobile device. In the cohort as a whole, there was a strong correlation between the QTc interval measurement on the standard 12-lead ECG and that recorded on the KardiaMobile device. The average difference in readings taken on the 12-lead ECG and the KardiaMobile device was 5ms, showing good agreement between the two tests. Poor quality ECG recordings occurred with similar frequency in the clinic and at home. 18% of recordings taken at home were affected by lead misplacement (i.e.: the KardiaMobile device was being held the wrong way round during the recording). Satisfaction questionnaires completed by patients and their parents showed that acceptability of the KardiaMobile devices was good.
Overall, the study found that the KardiaMobile 6L device is an accurate tool for assessing some of the ECG abnormalities associated with paediatric inherited cardiovascular disease and that it may provide a useful tool for remote monitoring of this patient group in the future.REC name
HSC REC B
REC reference
20/NI/0171
Date of REC Opinion
15 Dec 2020
REC opinion
Further Information Favourable Opinion