Pulmonary vein isolation alone or in combination with substrate modulation after electrical cardioversion failure in patients with persistent atrial fibrillation: The PACIFIC trial: Study design

Abstract

Introduction Pulmonary vein isolation (PVI) is effective at treating 50% of unselected patients with persistent atrial fibrillation (AF). Alternatively, PVI combined with a new ablation strategy entitled the Marshall‐PLAN ensures a 78% 1‐year sinus rhythm (SR) maintenance rate in the same population. However, a substantial subset of patients could undergo the Marshall‐PLAN unnecessarily. It is therefore essential to identify those patients who can be treated with PVI alone versus those who may truly benefit from the Marshall‐PLAN before ablation is performed. In this context, we hypothesized that electrical cardioversion (EC) could help to select the most appropriate strategy for each patient. Methods In this multicentre, prospective, randomized study, patients with AF recurrence within 4 weeks after EC will be randomized 1:1 to PVI alone or the Marshall‐PLAN. Conversely, patients in whom SR is maintained for ≥4 weeks after EC will be treated with PVI only and included in a prospective registry. The primary endpoint will be the 1‐year SR maintenance rate after a single ablation procedure. Results and Conclusion The Marshall‐PLAN might be necessary in patients with an advanced degree of persistent AF (i.e., where SR is not maintained for ≥4 uninterrupted weeks after EC). Conversely, in patients with mild or moderate persistent AF (i.e., where SR is maintained for ≥4 weeks after EC), PVI alone might be a sufficient ablation strategy. The PACIFIC trial is the first study designed to assess whether rhythm monitoring after EC could help to identify patients who should undergo adjunctive ablation strategies beyond PVI.