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

NCT06929897 | Enrolling By Invitation

• 1 other identifier: POBI-PFA
• Study Type: interventional
• Target: 482
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

pulsed field ablation; catheter ablation; posterior wall isolation; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• Recurrence of atrial tachyarrhythmia

  Freedom from documented AF/AT/AFL ≥30 seconds at 12 months post-procedure

  Within 12 months after the procedure, excluding the first 4-week blanking period

Secondary Outcomes (5)

• Peri-procedural complication

  Within 12 months after the procedure

• Total procedure time

  Periprocedural

• Length of hospital stay

  Within one year from the time of enrollment

• Atrial fibrillation burden assessed by Holter ECG

  Within 12 month from the time of enrollment

• patient satisfaction

  Within one year from the time of enrollment

Study Arms (2)

Additional Left Atrial Posterior Wall Ablation Group

ACTIVE COMPARATOR

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.

Procedure: Pulmonary Vein Isolation; Procedure: Additional Left Atrial Posterior Wall Ablation

Pulmonary Vein Isolation (PVI) only Group

PLACEBO COMPARATOR

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.

Procedure: Pulmonary Vein Isolation; Procedure: Non-PV trigger test

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.

Also known as: PVI

Additional Left Atrial Posterior Wall Ablation Group; Pulmonary Vein Isolation (PVI) only Group

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.

Pulmonary Vein Isolation (PVI) only Group

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.

Also known as: Posterior box isolation

Additional Left Atrial Posterior Wall Ablation Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 to 80 years who are candidates for catheter ablation for persistent atrial fibrillation
• Patients eligible for catheter ablation according to existing clinical guidelines
• Those without clinically significant structural heart disease (e.g., severe mitral regurgitation)
• Those without contraindications to anticoagulation therapy

You may not qualify if:

• Atrial fibrillation associated with severe congenital heart disease or structural heart disease
• Patients with contraindications to general anesthesia or sedation for the procedure
• History of prior cardiac surgery (e.g., Maze procedure, coronary artery bypass grafting)
• History of atrial fibrillation catheter ablation within the past 12 months
• Patients with severe left ventricular dysfunction (left ventricular ejection fraction \<30%)
• Patients with active internal bleeding
• Patients with contraindications to anticoagulation therapy and antiarrhythmic drugs
• Valvular atrial fibrillation (e.g., mitral stenosis \> grade 2, mechanical valve, prior mitral valve repair)
• Patients with severe comorbid conditions
• Patients with an expected survival of less than one year
• Patients with drug or alcohol addiction
• Pregnant or breastfeeding women
• Any other conditions deemed by the investigator to make the patient unsuitable for study participation

Sponsors & Collaborators

• Ewha Womans University Mokdong Hospital: lead
• Ewha Womans University Seoul Hospital: collaborator
• Korea University Anam Hospital: collaborator
• Kangbuk Samsung Hospital: collaborator
• Asan Medical Center: collaborator
• Severance Hospital: collaborator
• Samsung Medical Center: collaborator
• Chonnam National University Hospital: collaborator
• Daegu Catholic University Medical Center: collaborator

Study Sites (1)

Ewha Womans University Mokdong Hospitoal

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. Pulmonary vein isolation (PVI) is performed using pulsed-field ablation. After the procedure, electrical cardioversion is performed, and patients successfully converted to sinus rhythm are randomly assigned in a 1:1 ratio to either the PVI-only group or the PVI with additional left atrial posterior wall isolation group. 2. Patients who fail to convert to sinus rhythm after electrical cardioversion are excluded from randomization. 3. The target sample size is 482 patients, with 241 patients in each group. 4. Rhythm follow-up is performed at baseline, 3 months, 6 months, and 12 months using Holter monitoring or single-lead wearable ECG together with 12-lead ECG, with additional assessments when clinically indicated. 5. Outcomes include comparison of atrial tachyarrhythmia recurrence, procedural complications, procedure time, AF burden, and patient-reported satisfaction (AFEQT) between groups.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 16, 2025
• Study Start: July 3, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)