ORBICA-AF
Research type
Research Study
Full title
Objective Randomised Blinded Investigation of Cardioversion versus Ablation for persistent Atrial Fibrillation (ORBICA-AF)
IRAS ID
329483
Contact name
Richard Schilling
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Atrial Fibrillation (AF) is the commonest cardiac arrhythmia and a major cause of stroke. Until recently patients with persistent AF were often referred for cardioversion (an electric shock procedure to try to re-establish a normal heart rhythm).However,a newer technique of catheter ablation which aims to isolate the pulmonary vein using cryoablation has resulted in significantly less AF after treatment as well as symptom improvement and increased quality of life. There has been no blinded trial to compare these two procedures to see which one is better in early persistent AF. The results from such a trial could transform the care of our patients by providing an evidence base to guide treatment choices.
Our objective is to conduct a randomized, blinded trial that compares the efficacy of electrical cardioversion versus a pulmonary vein isolation approach for addressing persistent atrial fibrillation. We have meticulously formulated a comprehensive protocol for this trial, refining our methodologies based on insights gained from the pilot study. The pilot study's outcomes have demonstrated the viability of this research design, and our blinding techniques have effectively preserved the blinding of the assigned procedure from both patients and medical staff.
REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0331
Date of REC Opinion
4 Jun 2024
REC opinion
Further Information Favourable Opinion