NCT06929897

PVI Alone vs PVI With Posterior Wall Isolation for Pulse-Field Ablation in Persistent AF

Comparison of Pulmonary Vein Isolation Alone Versus Pulmonary Vein Isolation With Posterior Wall Isolation for Pulse-Field Ablation in Persistent Atrial Fibrillation: A Prospective Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Ewha Womans University Mokdong Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

To date, no optimal treatment has been established to improve outcomes in patients with persistent atrial fibrillation. The safety and efficacy of pulsed-field ablation (PFA) have been demonstrated in several studies, and its clinical application is expanding. \- In patients with persistent atrial fibrillation, can the addition of posterior wall isolation (PWI) following pulmonary vein isolation (PVI) using PFA reduce recurrence? Participants will: * Undergo either PVI alone or PVI with additional left atrial posterior wall isolation (PWI) * Visit the clinic to assess for recurrence of atrial tachyarrhythmias

Detailed description

Atrial fibrillation (AF) is a major cardiovascular disease with a prevalence of approximately 1.2% in the general population. It accounts for 20-25% of ischemic strokes and is associated with about 30% of heart failure cases. Catheter ablation is an interventional rhythm control strategy that has demonstrated superior outcomes compared to antiarrhythmic drugs (AADs) in patients with drug-refractory AF. For paroxysmal AF, pulmonary vein isolation (PVI) using radiofrequency catheter ablation or cryoballoon ablation has been shown to yield better clinical outcomes than medication alone. However, in persistent AF, additional ablation strategies beyond PVI have been investigated to improve procedural success rates. While previous studies explored the efficacy of linear ablation and complex fractionated electrogram (CFAE) ablation, recent research suggests that these additional ablation strategies do not significantly improve outcomes in persistent AF. As a result, the optimal catheter ablation strategy for persistent AF remains uncertain. Nonetheless, some studies have proposed left atrial posterior wall isolation (PWI) as a potential adjunct to reduce AF recurrence in patients with persistent AF. Pulsed-field ablation (PFA) has been recognized in both Europe and the United States for its safety and efficacy, offering a catheter ablation technique that enables a more effective and safer PVI. Additionally, PFA-based posterior wall isolation has been reported to facilitate rapid and safe lesion formation. Thus, this study aims to prospectively and randomly assign patients undergoing PFA for persistent AF to either: 1. PVI alone or 2. PVI with additional left atrial posterior wall isolation (PWI) By comparing outcomes between these two groups, this study seeks to determine the optimal ablation strategy for patients with persistent AF.

Conditions

• Atrial Fibrillation (AF)

Interventions

Type	Name	Description
PROCEDURE	Pulmonary Vein Isolation	1. Pulmonary vein isolation (PVI) is performed as the primary procedure. 2. After PVI, direct current (DC) cardioversion is performed to restore normal sinus rhythm. If the patient converts to sinus rhythm, they are randomly assigned to either the PVI-only group or the additional left atrial posterior wall ablation group. 3. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization.
PROCEDURE	Additional Left Atrial Posterior Wall Ablation	1. Additional left atrial posterior wall ablation is performed. 2. Complete electrical isolation of the entire left atrial posterior wall is confirmed (posterior box lesion isolation must be achieved). 3. Post-procedural rhythm monitoring follows the study protocol.
PROCEDURE	Non-PV trigger test	1. If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed. 2. Post-procedural rhythm monitoring follows the study protocol.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-05-01
• Completion: 2027-10-01
• First posted: 2025-04-16
• Last updated: 2025-04-16

Locations

1 site across 1 country: South Korea