Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

Traditional treatment options for persistent atrial fibrillation (PeAF) include pharmacological management, electrical cardioversion, and catheter ablation. Pulmonary vein isolation (PVI) has become the cornerstone of ablation therapy and has been shown to be effective in clinical practice. However, its efficacy is relatively limited in patients with persistent AF compared with those with paroxysmal AF, and many patients still experience recurrence after treatment.

In recent years, linear ablation strategies based on alcohol ablation have been shown to improve the one-year maintenance of sinus rhythm in patients with PeAF. Traditional radiofrequency ablation (RF) has demonstrated good outcomes but still has certain limitations when dealing with PeAF. In several clinical studies, pulsed field ablation (PFA), an emerging and innovative technique, has shown non-inferiority in treating paroxysmal AF. Furthermore, PFA has also demonstrated significant efficacy in linear ablation sites such as the mitral isthmus line, posterior left atrial wall, and tricuspid isthmus line, highlighting its potential in treating PeAF. This study aims to compare the safety and efficacy of PFA and radiofrequency ablation (RF) in the treatment of PeAF through a multi-center, prospective, randomized, open-label, non-inferiority clinical trial, to provide a safer and more effective treatment option for clinical practice.

• Freedom from any documented atrial arrhythmia in 12 months after the index ablation procedure [Срок оценки: From the end of the 3-month blanking period post-ablation to the 12-month follow-up]
• Freedom from any documented atrial fibrillation lasting for >30s in 12 months after the index ablation procedure (excluding a blanking period of 3 months) [Срок оценки: From the end of the 3-month blanking period post-ablation to the 12-month follow-up]
• Freedom from any documented atrial tachycardia and atrial flutter episodes in 12 months after the index ablation procedure [Срок оценки: From the end of the 3-month blanking period post-ablation to the 12-month follow-up]
• Freedom from any documented atrial arrhythmia in the absence of antiarrhythmic therapy in 12 months after multiple ablation procedure (excluding a blanking period of 3 months) [Срок оценки: From the end of the 3-month blanking period post-ablation to the 12-month follow-up]
• The atrial fibrillation burden (percentage of time) monitored over 12 months [Срок оценки: From the end of the 3-month blanking period post-ablation to the 12-month follow-up]
• Cardiovascular-related hospitalizations in 12 months after the index ablation procedure [Срок оценки: From the end of the 3-month blanking period post-ablation to the 12-month follow-up]
• Perioperative complications in 30 days after the index ablation procedure [Срок оценки: From the end of the ablation to the 30 days follow-up]