Marshall-Plan ablation strategy versus pulmonary vein isolation in persistent atrial fibrillation: Clinical trial design

Abstract

Background: Beyond pulmonary veins isolation (PVI), the ablation strategy that has prevailed over the past two decades remains controversial: (1) the left atrium partition using linear lesions ("cox-maze" strategy); (2) the mapping of the left atrium in atrial fibrillation (AF) to identify and localize the arrhythmia sources. Both methods have failed to demonstrate superiority compared to PVI alone. Whether the addition of a systematic vein of Marshall (VOM) ethanol infusion and empirical linear ablation to PVI (Marshall-Plan) improves outcomes in patients with persistent AF remains to be demonstrated.

Objectives: To compare the 2-year freedom from any atrial arrhythmia (atrial fibrillation [AF]/atrial tachycardia [AT]) between the Marshall-Plan approach and the PVI approach in patients with persistent AF.

Methods: The Marshall Plan is a multicenter, prospective, randomized, parallel- group, controlled clinical trial of superiority conducted in nine tertiary care centers across Europe (8 centers in France, 1 center in Belgium). A total of 262 patients will be randomized in two arms: Marshall-Plan, consisting of PVI with additional ablation, including vein of Marshall ethanol infusion, and lines of block at the mitral, dome, and cavotricuspid isthmuses versus PVI alone. The main outcome will be the 2-year freedom from any arrhythmia AF/AT <30 seconds) after a single ablation procedure with or without antiarrhythmic medication.

Conclusions: This randomized trial aims to determine the success and safety of adjunctive VOM ethanol infusion and linear ablation to PVI in patients with persistent AF.

Registration: URL: https://www.

Clinicaltrials: gov; Unique identifier: NCT04681872.