Inflammation, endothelial dysfunction and arrhythmia after AF ablation
Research type
Research Study
Full title
Post-ablation inflammatory response and endothelial function in the development of early recurrence of atrial tachyarrhythmia (ERAT) after pulmonary vein isolation; implications for pulmonary vein reconnection and freedom from atrial fibrillation
IRAS ID
262517
Contact name
Karan Saraf
Contact email
Sponsor organisation
The University of Manchester
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
Current guidelines recommend a 3 month 'blanking' period after catheter ablation for atrial fibrillation (AF). Early recurrence of arrhythmia in this period is common and in the first month is thought not to predict long term treatment failure, so repeat ablation is not recommended. Early recurrence is postulated to be due to an inflammatory response following ablation. Recurrence and persisting inflammation in months two or three are more predictive of late recurrence with radiofrequency (RF, heat energy) than cryoballoon (CB, cold energy) ablation. It is postulated that dysfunction of the endothelium (the lining of blood vessels and heart) may play a role in LR in the CB cohort, but not RF. Therefore if it can be demonstrated that persisting endothelial dysfunction and inflammation in the first few months following CB ablation can be predictive of LR, then performing early repeat ablation may improve patient morbidity, quality of life and reduce re-hospitalisation.
We will perform a pilot study of twenty patients undergoing clinically indicated first-time AF ablation, randomised to RF or CB ablation (both first-line standard of care techniques), assess post-ablation inflammatory response, endothelial function and degree of early recurrence. This pilot data will inform a larger study and determine whether patient outcomes can be improved by using these markers to predict who will develop late recurrences of arrhythmia and therefore require early re-intervention rater than experiencing late recurrence and subsequent morbidity. The study will run at Manchester University NHSFT together with the University of Manchester for approximately one year. Patients will have AF ablation and insertion of a small heart monitor underneath their skin to monitor for arrhythmia post-procedure. They will have blood tests for inflammation markers and non-invasive endothelial function testing pre-procedure and at their follow-up outpatient appointments. The study has been funded by Medtronic Plc, a medical devices company.
REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/0764
Date of REC Opinion
29 Jul 2020
REC opinion
Further Information Favourable Opinion