A randomized controlled trial of pulsed field ablation vs antiarrhythmic therapy as a first-line treatment for persistent atrial fibrillation: The AVANT GUARD trial rationale and design.
BACKGROUND: Recent studies have established catheter ablation as a safe and superior alternative to antiarrhythmic drugs (AADs) as a first-line therapy in patients with paroxysmal atrial fibrillation (AF). There are no randomized controlled trials assessing this strategy in patients with persistent AF. OBJECTIVE: This study aims to establish the safety and effectiveness of pulsed field ablation (PFA) as a first-line treatment for persistent AF compared with AAD therapy. METHODS: AVANT GUARD (A Prospective Randomized Multicenter Global Study Comparing Pulsed Field Ablation vs Anti-Arrhythmic Drug Therapy as a First Line Treatment for Persistent Atrial Fibrillation) is a multicenter, global, pivotal investigational device exemption study that compares the safety and effectiveness of PFA with the pentaspline PFA catheter to AADs as first-line therapy for patients with persistent AF. All patients will receive an implantable cardiac monitor. RESULTS: The primary safety end point, evaluated in PFA subjects, is a composite of defined acute and chronic device- and procedure-related serious adverse events. The primary effectiveness end point, evaluated in randomized PFA and AAD subjects at 12-month follow-up, is a composite of acute and chronic treatment success including freedom from atrial arrhythmia recurrence lasting ≥30 seconds (symptomatic) or ≥1 hour (asymptomatic), electrical cardioversion, or (re)ablation. CONCLUSION: AVANT GUARD will help fill a critical gap in our understanding of treatment approaches and disease progression for patients with persistent AF by providing a direct comparison between ablation using PFA versus AAD treatment as a first-line therapy with continuous monitoring to assess outcomes.
