Objective Randomised Blinded Investigation of Cardioversion Versus Ablation for Persistent Atrial Fibrillation (ORBICA-AF)

What this Trial Is About

Researchers are evaluating whether patients with persistent atrial fibrillation (AF) treated by pulmonary vein isolation with catheter ablation will experience fewer recurrences of AF compared to those treated with direct current (DC) cardioversion without ablation. This trial addresses the lack of blinded randomized controlled studies comparing early ablation to cardioversion-led strategies. The study aims to clarify the true benefits of ablation on symptoms and arrhythmia in persistent AF patients who remain symptomatic despite stroke prevention and rate control. Participants will receive either pulmonary vein isolation catheter ablation combined with DC cardioversion or DC cardioversion with a sham procedure. Before randomization, an implantable loop recorder is placed to monitor heart rhythm continuously. The procedure involves insertion of femoral sheaths for catheter access and, for the ablation group, circumferential ablation around pulmonary veins to electrically isolate them. The sham group receives intermittent phrenic nerve pacing to mimic the procedure. DC cardioversion is performed as needed to restore normal heart rhythm. Throughout the study, participants will be monitored using the implanted loop recorder to track AF episodes and burden at 3, 6, and 12 months. Additional assessments include quality of life questionnaires, hospital readmissions, procedural complications, cardiac function, and antiarrhythmic drug use. The main outcomes are recurrence of persistent AF and changes in AF burden within one year. Safety and symptom measures will also be evaluated to understand the impact of each treatment strategy.

Investigation of Cardioversion Versus Therapeutic Ablation for Persistent AF (ORBICA-AF)