Rationale and design of a multicenter randomized trial of adjunctive non-pulmonary vein trigger ablation in persistent atrial fibrillation: The EXPORT trial.

BACKGROUND: Pulmonary vein (PV) isolation in paroxysmal atrial fibrillation (AF) is strongly endorsed with a class IA recommendation for those with symptomatic AF who are refractory to antiarrhythmic drug (AAD) therapy to reduce symptoms, recurrence, and disease progression. However, in persistent AF, the efficacy of PV isolation alone is less pronounced than in paroxysmal AF, underscoring the necessity of adjunctive ablation strategies. Whether ablation of non-PV triggers after PV isolation improves the long-term procedure outcome is unknown. The EXPORT trial aims to evaluate the effects of systematic non-PV trigger ablation over PV isolation alone on freedom from atrial tachyarrhythmia recurrence among participants with persistent AF.

STUDY DESIGN: The EXPORT trial is a multicenter, prospective, superiority, single-blinded, blinded-endpoint, clinical trial. Participants with persistent AF refractory to AAD therapy undergoing first-time AF ablation will be randomly assigned to either PV isolation with non-PV trigger provocation, mapping, and ablation or PV isolation alone. The primary endpoint is any documented atrial arrhythmia lasting ≥30 s after a 3-month blanking period following ablation with or without the use of AADs. Key secondary endpoints are freedom from atrial arrhythmia recurrence without AAD use, periprocedural complications, and total procedure time. The estimated total sample size is 430 participants, with 215 participants in each group.

CONCLUSION: The EXPORT trial will assess the effect of non-PV trigger mapping and ablation with PV isolation on freedom from atrial tachyarrhythmia recurrence in participants with persistent AF.

TRIAL REGISTRATION: Clinicaltrials.gov; NCT07197931.