ASD Arrhythmia Study
Research type
Research Study
Full title
Characterisation of the Structural and Electrical Impact of an Atrial Septal Defect
IRAS ID
205645
Contact name
Mark O'Neill
Contact email
Sponsor organisation
Guy's and St. Thomas' Foundation Trust
Duration of Study in the UK
3 years, 1 months, 30 days
Research summary
An atrial septal defect (ASD) is a common type of congenital heart disease consisting of an abnormal communication or hole (shunt) between the top chambers of the heart (atria). Treatment includes closure of the ASD either surgically or percutaneously - which involves insertion of a closure device through a vein in the groin.
ASDs are associated with structural and electrical changes in the atria which in turn are associated with rhythm disturbances or atrial arrhythmias (AAs), however little is known about the nature of these changes and whether they reverse after closure of the ASD.
This study aims to describe the structural and electrical impact of ASDs using imaging and invasive modalities.
Fifty-five adult patients with ASDs (with and without AAs) planned for surgical or percutaneous closure with will be enrolled. All patients will undergo cardiac MRI (CMR) prior to closure to quantify structural changes such as atrial fibrosis (scarring).
Patients undergoing percutaneous closure will have electrical measurements performed at the same time as their closure procedure.
All patients will undergo repeat CMR at one year post closure to assess for reversibility of structural changes. Patients who underwent percutaneous ASD closure with electrical measurements will undergo a limited electrophysiology (electrical recording)
study at one year to assess for reversibility of electrical changes.A control group of 28 non ASD patients planned for an invasive procedure for atrial fibrillation treatment will be included. They will undergo pre and post procedural imaging and intra procedural electrical evaluation as described above.
A better understanding of the basis for arrhythmias will enable existing clinical tools used to treat arrhythmias in non- ASD patients to be applied to ASD patients. This is important since once the ASD is closed it becomes very challenging to access the left atrium, meaning arrhythmias in heart chamber are difficult to treat.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/1218
Date of REC Opinion
4 Sep 2017
REC opinion
Further Information Favourable Opinion