Atrial fibrillation (AF), the most common arrhythmia, accounts for 1/3rd of cardiovascular expenses, with over 10 million affected in Europe. In addition to significant impact on quality of life, AF exposes patients to stroke, heart failure, dementia and death. This arrhythmia is characterized by abnormalities in electrical impulse formation and conduction within the heart.
Pulmonary Vein Isolation (PVI) is the cornerstone of AF ablation, preventing arrhythmia recurrences. Catheter ablation of AF uses either radio frequency (RF) or cryothermal (cryo) energy. Common to these thermal energy sources is the fact that these modalities ablate all tissue types indiscriminately, exposing patients to some complications. The ablation procedure remains long, requires skills and expertise, and has a limited success rate, mostly because of non-durable lesions after PVI implying frequent redo procedures. These energies are associated with rare but severe complications due to their thermal nature. It remains suboptimal with safety and efficacy issues, and can only be delivered by highly trained specialists. Complications and duration of the procedure itself directly affect the time spent in the operating theatre and hospital as well as associated costs.
The goal of BEAT AF is to disrupt AF ablation by achieving durable PVI with permanent, coalescent and transmural ablation lesions using Pulsed Electric Field (PEF) energy. PEF is non-thermal and creates nanoscale pores in cell membranes. This energy has some tissue selectivity: cardiac cells are highly sensitive to PEF unlike phrenic and esophageal cells. BEAT AF aims to demonstrate that PEF ablation is faster, more effective and safer (tissue selectivity) than RF or cryo ablation. For this purpose, two distinct randomized clinical trials will be conducted: 1) to provide first comparative evidence of the superiority of PEF over RF on the rate of 1-year recurrence for paroxysmal AF, and 2) to provide first evidence of potential efficacy of PEF on the rate of 1-year clinical recurrence for persistent AF. The BEAT AF consortium gathers 9 European renowned clinical centres (France, Czech Republic, Germany, Austria, Belgium) to set the ground for large trials and contribute to decrease the huge burden of AF in Europe.
