The relationship Between Fragmented QRS and Arrhythmic Events, 1.0
Research type
Research Study
Full title
The relationship Between Fragmented QRS and Ventricular Arrhythmic Events in Patients with Non-Ischaemic Cardiomyopathy: The Challenges of Appropriate ICD Implantation for Primary Prevention
IRAS ID
343792
Contact name
Roslyn Milligan
Contact email
Sponsor organisation
Newcastle University
Duration of Study in the UK
0 years, 6 months, 19 days
Research summary
An implantable cardioverter-defibrillator is a device which is implanted into a patient’s chest if they have a risk of developing abnormal heart rhythms. The device works by sending electrical impulses which can return the heart rhythm to normal, however, deciding which patients will benefit from these devices has been an ongoing debate. Primary prevention describes patients which receive this device as they have an increased risk of developing abnormal heart rhythms. However, the research surrounding which primary prevention patients will actually benefit from the device is ill-defined due to the lack of trials. The vast majority of primary prevention patients which receive the device due to a genetic cause are of a young age and this device significantly increases their risk of future complications. Not only can the device itself malfunction and cause infection but the devices have shown to have an effect on patients psychological status with many becoming depressed or anxious.
This research aims to identify which patients will benefit from the device by determining if they have abnormal electrical ‘waves’ on their electrocardiogram. This is a heart test which measures the electrical activity in the heart and an abnormal ‘wave’ is believed to represent an area of heart muscle which promotes abnormal heart rhythms to occur. The study will use primary prevention patients which have received the device and determine whether the abnormal wave are seen more frequently in those which required the device due to having abnormal heart rhythms. If the abnormal waves can be shown to increase the likelihood of developing abnormal heart rhythms, then this could be a possible solution for identifying which patients would have a benefit from the device. Without more accurate guidelines patients receiving the device and not requiring them are reducing their quality of life with no real benefits.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
25/WM/0046
Date of REC Opinion
21 Mar 2025
REC opinion
Further Information Favourable Opinion