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

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: Not yet recruiting
• Conditions: Atrial Fibrillation (AF)
• Intervention / Treatment: Procedure: Pulmonary Vein Isolation; Procedure: Additional Left Atrial Posterior Wall Ablation; Procedure: Non-PV trigger test

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.

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junbeom Park, M.D., Ph.D.; Phone Number: +82-02-2650-5826; Email: newriser@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Ewha Womans University Mokdong Hospitoal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Additional Left Atrial Posterior Wall Ablation Group; After pulmonary vein isolation, electrical isolation of the left atrial posterior wall is performed using a pulsed-field ablation catheter with EGM-guided ablation.	Procedure: Pulmonary Vein Isolation; 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.; Other Names: PVI; Procedure: Additional Left Atrial Posterior Wall Ablation; Additional left atrial posterior wall ablation is performed.; Complete electrical isolation of the entire left atrial posterior wall is confirmed (posterior box lesion isolation must be achieved).; Post-procedural rhythm monitoring follows the study protocol.; Other Names: Posterior box isolation
Placebo Comparator: Pulmonary Vein Isolation (PVI) only Group; Electrical isolation of all four pulmonary veins is performed using a pulsed-field ablation catheter.	Procedure: Pulmonary Vein Isolation; 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.; Other Names: PVI; Procedure: Non-PV trigger test; If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed.; 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	Clinical recurrence rate of atrial fibrillation within one year after the procedure.	Within one year from the time of enrollment, excluding the first three months after the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-procedural complication	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 one year from the time of enrollment
Total procedure time	total procedure time	Periprocedural
Length of hospital stay	Length of hospital stay	Within one year from the time of enrollment
patient satisfaction	Atrial Fibrillation Effect on Quality-of-Life(AFEQT)	Within one year from the time of enrollment
Atrial fibrillation burden	Atrial fibrillation burden (%) recorded via holter ECG	Within one year from the time of enrollment

Collaborators and Investigators

• Sponsor: Ewha Womans University Mokdong Hospital
• Collaborators: Asan Medical Center; Korea University Anam Hospital; Seoul National University Bundang Hospital; Korea University Guro Hospital; Ajou University School of Medicine; Kangbuk Samsung Hospital; Severance Hospital; Hanyang University Seoul Hospital; Wonkwang University Hospital; Ewha Womans University Seoul Hospital; Eunpyeong St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027

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): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: atrial fibrillation; catheter ablation; posterior wall isolation; pulsed field ablation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• 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