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Enrolling by Invitation

NCT Number: NCT06929897

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

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

Enrolling by Invitation

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ewha Womans University Mokdong Hospitoal

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pulmonary vein isolation

Procedure
  • 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

Additional Left Atrial Posterior Wall Ablation

Procedure
  • 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

Non-PV trigger test

Procedure
  • If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed.
  • Post-procedural rhythm monitoring follows the study protocol.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Total procedure time

    Time frame: Periprocedural

    total procedure time

  3. Length of hospital stay

    Time frame: Within one year from the time of enrollment

    Length of hospital stay

  4. 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.

  5. patient satisfaction

    Time frame: Within one year from the time of enrollment

    Atrial Fibrillation Effect on Quality-of-Life(AFEQT)

Sponsors and collaborators

Lead sponsor

Ewha Womans University Mokdong Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: POBI-PFA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 16, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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