NCT06791629

Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation

Pulsed Field Ablation Versus Radiofrequency Ablation for Persistent Atrial Fibrillation: A Randomized, Open-label, Non-inferior Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 700 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to compare the efficacy and safety of pulsed field ablation and radiofrequency ablation to treat persistent atrial fibrillation in adults. Participants will: Undergo pulsed field ablation or radiofrequency ablation. Keep follow-up for at least 12 months.

Detailed description

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.

Conditions

• Persistent Atrial Fibrillation
• Radiofrequency Catheter Ablation
• Pulsed Field Ablation

Interventions

Type	Name	Description
DEVICE	Pulsed Field Ablation	Patients will be treated with pulsed field ablation for atrial fibrillation.
DEVICE	Radiofrequency Ablation	Patients will be treated with radiofrequency ablation for atrial fibrillation.

Timeline

• Start date: 2025-02-15
• Primary completion: 2026-12-15
• Completion: 2027-02-15
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: China