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

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

Conditions

• Atrial Fibrillation (AF)

Interventions

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

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

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.

Sponsors & Collaborators

• Ewha Womans University Seoul Hospital

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Ajou University School of Medicine

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Kangbuk Samsung Hospital

  collaborator OTHER

• Hanyang University Seoul Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Wonkwang University Hospital

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Eunpyeong St. Mary's Hospital

  collaborator OTHER

• Ewha Womans University Mokdong Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2027-05-01

Completion

2027-10-01

Countries

• South Korea

Study Locations