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

Official 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

Overview

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

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.

Interventions

• 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.
• 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.
• 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.

Primary outcome measures

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

Secondary outcome measures (5)

• Peri-procedural complication [Time frame: Within 12 months after the procedure]
• Total procedure time [Time frame: Periprocedural]
• Length of hospital stay [Time frame: Within one year from the time of enrollment]
• Atrial fibrillation burden assessed by Holter ECG [Time frame: Within 12 month from the time of enrollment]
• patient satisfaction [Time frame: Within one year from the time of enrollment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

South Korea · 1 center

• Ewha Womans University Mokdong Hospitoal — Seoul

Identifiers

NCT: NCT06929897 · POBI-PFA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗