PVI Alone vs PVI With Posterior Wall Isolation for Pulse-Field Ablation in Persistent AF (POBI-PFA)

July 15, 2026 updated by: Ewha Womans University Mokdong Hospital

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Atrial fibrillation is a major cardiovascular disease, and catheter ablation has become an established rhythm-control strategy that provides superior outcomes compared with pharmacological therapy in patients with drug-refractory atrial fibrillation. Although the efficacy of pulmonary vein isolation (PVI) is well established in patients with paroxysmal atrial fibrillation, the effectiveness of additional ablation strategies beyond PVI remains uncertain in patients with persistent atrial fibrillation.

Several studies have suggested that left atrial posterior wall isolation (PWI) may help reduce recurrence; however, conventional thermal ablation techniques have been limited by technical challenges in achieving durable lesion formation. Pulsed field ablation (PFA) is a nonthermal ablation technology that creates selective myocardial lesions, enabling rapid and consistent lesion formation while minimizing injury to surrounding tissues.

This study aims to prospectively and randomly compare PVI alone using PFA with PVI followed by additional PWI in patients with persistent atrial fibrillation. By evaluating recurrence rates, procedure time, complications, atrial fibrillation burden, and patient satisfaction, this study seeks to identify the optimal ablation strategy for patients with persistent atrial fibrillation.

Study Type

Interventional

Enrollment (Estimated)

482

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea
        • Ewha Womans University Mokdong Hospitoal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • PVI
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.
Other Names:
  • Posterior box isolation
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.
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.
Other Names:
  • PVI
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of atrial tachyarrhythmia
Time Frame: Within 12 months after the procedure, excluding the first 4-week blanking period
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total procedure time
Time Frame: Periprocedural
total procedure time
Periprocedural
Length of hospital stay
Time Frame: Within one year from the time of enrollment
Length of hospital stay
Within one year from the time of enrollment
patient satisfaction
Time Frame: Within one year from the time of enrollment
Atrial Fibrillation Effect on Quality-of-Life(AFEQT)
Within one year from the time of enrollment
Peri-procedural complication
Time Frame: Within 12 months after the procedure
Major ; brain hemorrhage, thromboembolism , atrial -esophageal fistula, pericardial effusion, tamponade, irreversible phrenic nerve palsy, bleeding requiring transfusion, Pulmonary Vein Stenosis: Minor ; puncture site bleeding not requiring transfusion , groin hematoma, reversible phrenic nerve palsy
Within 12 months after the procedure
Atrial fibrillation burden assessed by Holter ECG
Time Frame: Within 12 month from the time of enrollment
Atrial fibrillation burden will be calculated as the percentage of the total analyzable Holter ECG monitoring time spent in atrial fibrillation or atrial tachyarrhythmia. Values range from 0% to 100%, with higher percentages indicating a greater atrial fibrillation burden and therefore a worse outcome.
Within 12 month from the time of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University Mokdong Hospital

Collaborators

Samsung Medical Center
Asan Medical Center
Chonnam National University Hospital
Korea University Anam Hospital
Daegu Catholic University Medical Center
Kangbuk Samsung Hospital
Severance Hospital
Ewha Womans University Seoul Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2026

Primary Completion (Estimated)

June 30, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 16, 2025

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POBI-PFA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and the lack of specific consent for data sharing obtained during the study enrollment process.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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