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

Sponsor
Ewha Womans University Mokdong Hospital
Study ID
NCT06929897
Status
Enrolling By Invitation

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Pulmonary Vein Isolation — PROCEDURE
    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.
  • Additional Left Atrial Posterior Wall Ablation — PROCEDURE
    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.
  • Non-PV trigger test — PROCEDURE
    1. If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed. 2. Post-procedural rhythm monitoring follows the study protocol.

Study Details

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

Key Dates

First listed
Apr 16, 2025
Start date
Jul 3, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
482 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Additional Left Atrial Posterior Wall Ablation Group
    Pulmonary vein isolation (PVI) is performed as the primary procedure. 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. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo additional left atrial posterior wall isolation using pulsed field ablation. Before completion of the procedure, electrical isolation of both the pulmonary veins and the left atrial posterior wall will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol.
  • Placebo Comparator: Pulmonary Vein Isolation (PVI) only Group
    Pulmonary vein isolation (PVI) is performed as the primary procedure. 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. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization. Patients assigned to this group after successful conversion to normal sinus rhythm by electrical cardioversion following PVI will undergo no additional left atrial posterior wall isolation. Before completion of the procedure, electrical isolation of the pulmonary veins will be confirmed. Thereafter, anticoagulation therapy and rhythm follow-up will be performed according to the study protocol.

Primary Outcome Measure

Recurrence of atrial tachyarrhythmia [ Time Frame: Within 12 months after the procedure, excluding the first 4-week blanking period ]

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