PVI Alone vs PVI With Posterior Wall Isolation for Pulse-Field Ablation in Persistent AF (POBI-PFA)

Ewha Womans University

Status: Not yet enrolling

Conditions: Atrial Fibrillation (AF)

Treatments: Procedure: Pulmonary Vein Isolation; Procedure: Additional Left Atrial Posterior Wall Ablation; Procedure: Non-PV trigger test

Study type: Interventional

Funder types: Other

Identifiers

NCT06929897

POBI-PFA

Details and patient eligibility

About

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

Full 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.

Enrollment: 214 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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214 participants in 2 patient groups, including a placebo group

Additional Left Atrial Posterior Wall Ablation Group

Active Comparator group

Description:

After pulmonary vein isolation, electrical isolation of the left atrial posterior wall is performed using a pulsed-field ablation catheter with EGM-guided ablation.

Treatment:

Procedure: Additional Left Atrial Posterior Wall Ablation

Procedure: Pulmonary Vein Isolation

Pulmonary Vein Isolation (PVI) only Group

Placebo Comparator group

Description:

Electrical isolation of all four pulmonary veins is performed using a pulsed-field ablation catheter.

Treatment:

Procedure: Non-PV trigger test

Procedure: Pulmonary Vein Isolation