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Atrial fibrillation (AF) typically progresses from paroxysmal (PAF) to persistent (PersAF) and ultimately to permanent forms due to advancing atrial structural remodeling and the progression of atrial cardiomyopathy. Early treatment can help mitigate irreversible structural changes and prevent adverse AF-related outcomes.
PersAF constitutes about 25% of total AF cases1. Compared to patients with PAF, those with PersAF face higher risks of cardiac mortality and all-cause mortality2. Recent 2024 guidelines recommend catheter ablation as a first-line treatment for PAF3. Since most first-line trials have focused on PAF, it is still unknown if PersAF patients could benefit from ablation as a first-line therapy vs anti-arrhythmic drugs (AADs).
The AVANT GUARD clinical trial seeks to demonstrate that FARAPULSE™* Pulsed Field Ablation (PFA) is safe and effective as a first-line treatment for patients with PersAF compared to patients who received initial treatment with AADs3,4. Should the study demonstrate superior outcomes with PFA as a first-line therapy, it could revolutionize clinical practices, enhancing patient care and quality of life for those with persistent AF.
* CAUTION: Investigational device. Limited by US law to investigational use only. Not available for sale.
The AVANT GUARD trial is a prospective, randomized, multicenter, global, pivotal IDE study. Subjects with PersAF will be randomized to either ablation with FARAPULSE PFA or AAD treatment. The FARAPULSE PFA System is under an FDA investigational device* exemption usage for patients with PersAF.
AADs including, Flecainide, Sotalol, Propafenone, and Dofetilide will be prescribed and monitored under local clinical practice and already established guideline-directed therapy for patients with persistent AF.
The recent update of the 2024 EHRA/HRS/APHRS/LAHRS consensus statement on catheter ablation now recommends catheter ablation as a first-line treatment for symptomatic PAF patients3. For PersAF, more research is needed but catheter ablation may be reasonable as a first-line treatment in symptomatic patients3. Additionally, the 2023 ACC/AHA/ACCP/HRS AF ablation guidelines upgraded catheter ablation as first-line treatment to a class 1 indication for patients with symptomatic PAF to improve symptoms and reduce progression to PersAF4. Catheter ablation in PersAF patients as first-line therapy is a class 2a indication.4
PFA is a novel non-thermal cardiac ablation modality. In PFA ultra-rapid electrical pulses are applied to the cardiac tissue, destabilizing the cell membrane and causing the cell’s contents to exit resulting in cell death.
Since receiving the CE mark in 2021 and FDA approval in 2024, the FARAPULSE Pulsed Field Ablation System has treated over 70,000 patients. It boasts extensive global use, supported by large-scale registries and independent clinical studies, with more trials currently in progress.
Throughout this journey, we have continuously refined, optimized, and validated pulsed field ablation therapy to enhance its efficacy and safety.
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