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

N/AEnrolling By InvitationNCT06929897

Ewha Womans University Mokdong Hospital482 enrolled

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Interventions

Pulmonary Vein IsolationPROCEDURE

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.

Additional Left Atrial Posterior Wall AblationPROCEDURE

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.

Non-PV trigger testPROCEDURE

1. If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed. 2. Post-procedural rhythm monitoring follows the study protocol.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recurrence of atrial tachyarrhythmia

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

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

Secondary Outcomes

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

Time frame: Within 12 months after the procedure

Total procedure time

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

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.

Time frame: Within 12 month from the time of enrollment

patient satisfaction

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