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

NCT06929897 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2026-07-03
Last updated
2026-07-16

Condition(s) studied

Atrial Fibrillation (AF)

Investigational drug(s) / intervention(s)

Pulmonary Vein IsolationAdditional Left Atrial Posterior Wall AblationNon-PV trigger test

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.

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.

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.

Study summary

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

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Recurrence of atrial tachyarrhythmia — 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

Trial sites (1)

FacilityCityRegionStatus
Ewha Womans University Mokdong Hospitoal Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06929897 on ClinicalTrials.gov ↗ ← All trials in South Korea