The Utility of Subcutaneous ICDs in the ACHD Population
Research type
Research Study
Full title
Assessing the Utility of Subcutaneous Implantable Cardioverter-Defibrillators in the Adult Congenital Heart Disease Population
IRAS ID
197975
Contact name
Joseph De Bono
Contact email
Sponsor organisation
University Hospital Birmingham NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 14 days
Research summary
The purpose of this study is to investigate what proportion of adult congenital heart disease (ACHD) patients are suitable for a subcutaneous implantable cardioverter-defibrillator (S-ICD), an alternative to the usual trans-venous device. This new type of defibrillator does not attach to the heart and the leads are not inserted through the veins. It has limited programmable features and does not allow programming of anti-tachycardia pacing. Some people have unsuitable features on their electrocardiogram (ECG) for this device, which would affect its ability to provide appropriate shock therapy. Therefore, prior to implant a screening ECG test must be carried out to assess eligibility. The European Society of Cardiology recommends S-ICD use in the ACHD population, as trans-venous ICD implantation is challenging due to their complex anatomy and increased risk of procedural complications. However, research within the ACHD population is limited regarding suitability of the S-ICD. Therefore, the main aspect of this study is to carry out the ECG screening in a large study sample consisting of three ACHD cohorts, during their routine visit to clinic. This will be compared to data from the general population. A subset of these patients who are completing a routine exercise test will also have the screening ECG performed post-exercise. Recruitment will take place during the patient's routine visit to outpatient clinic at a single quaternary centre, providing specialist ACHD services. Furthermore, retrospective analysis of medical records will take place, in order to investigate the utility of anti-tachycardia pacing in trans-venous devices already implanted in the total ACHD population. In addition the number of trans-venous explants that occur in this single centre will be reviewed. The possible benefits of the study are that it may help to inform the potential clinical use of the device and may initiate further research as a consequence.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0255
Date of REC Opinion
5 Jul 2016
REC opinion
Further Information Favourable Opinion