NCT06866704

Pulsed-Field Ablation vs. Radiofrequency Ablation CombIned With Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation

Pulsed-Field Ablation vs. Radiofrequency Ablation CombIned With Vein of Marshall Ethanol Ablation on Mitral Isthmus Block and Clinical Outcomes in Persistent Atrial Fibrillation: The PRIME-AF Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 154 (estimated)
• Sponsor: lingzhiyu · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Atrial fibrillation (AF) is one of the most common clinical arrhythmias, and catheter ablation serves as a critical therapeutic approach. For persistent atrial fibrillation, several proposed ablation strategies-including the 2C3L technique, BOX lesion sets, and substrate modification-remain highly controversial regarding long-term success rates. Multiple studies suggest that linear ablation beyond pulmonary vein isolation (PVI) often fails to achieve durable block due to incomplete ablation lines, which significantly contributes to postoperative recurrence of atrial arrhythmias. In recent years, electrophysiologists have explored various methods to improve mitral isthmus (MI) ablation, such as combined endo-epicardial ablation and radiofrequency ablation (RFA) combined with Marshall vein alcohol ablation. While RFA combined with anhydrous alcohol injection into the Marshall vein enhances MI block rates, it is associated with prolonged procedure time, unpredictable ablation zones, and higher complication risks (e.g., coronary artery spasm, pericarditis). Pulsed field ablation (PFA), an emerging non-thermal ablation technology, offers potential advantages such as tissue selectivity, shorter procedure time, and fewer complications. Studies report that RFA achieves near 100% immediate block rates; however, there is a lack of sufficient comparative studies on the efficacy and safety between these two ablation approaches. This study aims to compare the clinical outcomes and safety profiles of PFA versus RFA combined with Marshall vein alcohol injection in patients with persistent AF.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
PROCEDURE	catheter ablation	In the experimental group, patients receive pulsed field ablation (PFA) to achieve pulmonary vein isolation (PVI), circumferential BOX ablation around bilateral pulmonary veins, and mitral isthmus ablation. In the control group, anhydrous alcohol is first injected into the Marshall vein, followed by radiofrequency catheter ablation to complete PVI, BOX lesion sets, and mitral isthmus ablation.

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2025-03-10
• Last updated: 2025-03-11