Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination (ADVICE): Methods and Rationale

Background: Pulmonary vein (PV) isolation (PVI) has emerged as an effective therapy for paroxysmal atrial fibrillation (AF). However, AF recurs in up to 50% of patients, generally because of recovery of PV conduction. Adenosine given during the initial procedure may reveal dormant PV conduction, thereby identifying the need for additional ablation, leading to improved outcomes. The Adenosine Following Pulmonary Vein Isolation to Target Dormant Conduction Elimination (ADVICE) study is a prospective multicentre randomized trial assessing the impact of adenosine-guided PVI in preventing AF recurrences. Methods: Patients undergoing a first PVI procedure for paroxysmal AF will be recruited. After standard PVI is completed, all patients will receive intravenous adenosine in an attempt to unmask dormant conduction. If dormant conduction is elicited, patients will be randomized to no further ablation (control group) or additional adenosine-guided ablation until dormant conduction is abolished. If no dormant conduction is revealed, randomly selected patients will be followed in a registry. The primary outcome is time to first documented symptomatic AF recurrence. Assuming that dormant conduction is present in 50% of patients post PVI and symptomatic AF recurs in 45% of controls, 244 patients with dormant conduction will be required to obtain >90% power to detect a difference of 20%. Thus, a total of 488 patients will be enrolled and followed for 12 months. Conclusion: The ADVICE trial will assess whether a PVI strategy incorporating elimination of dormant conduction unmasked by intravenous adenosine will decrease the rate of recurrent symptomatic AF compared with standard PVI.