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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation (AF)

• Registration Number: NCT06929897
• Lead Sponsor: Ewha Womans University Mokdong Hospital

Brief 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

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 Timeline

• Study First Submitted: 2025-03-13
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-16
• Last Update Posted: 2025-04-16
• Study Start: 2025-05-01
• Primary Completion: 2027-05-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 214

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrence of atrial tachyarrhythmia	Within one year from the time of enrollment, excluding the first three months after the procedure	Clinical recurrence rate of atrial fibrillation within one year after the procedure.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ewha Womans University Mokdong Hospitoal; 🇰🇷 Seoul, Korea, Republic of