Validation of AliveCor system for Detection of Cardiac Arrhythmias
Research type
Research Study
Full title
Validation of a smartphone-based Recorder for Detection of Cardiac arrhythmias
IRAS ID
245687
Contact name
Khalid Abozguia
Contact email
Sponsor organisation
Blackpool Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The AliveCor Heart Monitor is a pocket‑sized rectangular device containing 2 electrodes. It is either attached directly via an adhesive attachment plate to a mobile device or must be within 30 cm of the mobile device during operation. The mobile device must be a standard internet‑enabled mobile phone or tablet, onto which the AliveECG app must be downloaded.
The objective of the study is to test whether the AliveCor device will be non-inferior to the 12 lead ECG with respect to diagnosis of various cardiac arrhythmias (atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, paced rhythm, supraventricular tachycardia). There are no validated studies to evaluate its use in arrhythmias other than AF.
We are planning to record 300 abnormal ECGs (50 each of atrial fibrillation, atrial flutter, pre-excitation, ventricular tachycardia, paced rhythm, supraventricular tachycardia) and 150 control ECGs (100 sinus rhythm, 50 sinus tachycardia) using both the AliveCor Smartphone device and a 12-lead ECG. A 30-second ECG tracing will be obtained by simply holding the Smartphone and placing at least 1 finger from each hand on electrodes embedded into the back of the Smartphone case. For sedated patients in the cath lab, Alivecor electrodes will be placed and taped on patient chest wall. A 12-lead ECG will also be recorded as near to simultaneously as possible.
Every patient will be counselled about the project. Patients will be given up to 2 weeks to consider their participation. If in agreement, written informed consent will be obtained.
There are several different portable ECG recorders available to the NHS for diagnosing paroxysmal arrhythmias. The AliveCor Heart Monitor could be used as an alternative to these recorders. This may produce savings to the NHS as the AliveCor Heart Monitor costs £62.49, whereas the mean cost of other ECG recorders is £170.REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/1121
Date of REC Opinion
2 Aug 2018
REC opinion
Further Information Favourable Opinion