Clinical trial NCT06929897: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: pulsed field ablation
catheter ablation
posterior wall isolation
atrial fibrillation
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
Collaborators: name: Ewha Womans University Seoul Hospital
name: Korea University Anam Hospital
name: Ajou University School of Medicine
name: Seoul National University Bundang Hospital
name: Kangbuk Samsung Hospital
name: Hanyang University Seoul Hospital
name: Asan Medical Center
name: Wonkwang University Hospital
name: Korea University Guro Hospital
name: Severance Hospital
name: Eunpyeong St. Mary's Hospital
First posted: 2025-04-16
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pulmonary vein isolation (PVI) is performed using pulsed-field ablation. Afterward, electrical cardioversion is performed to restore normal sinus rhythm. Patients who successfully convert to sinus rhythm are then randomly assigned to either the PVI-only group or the PVI with additional left atrial posterior wall isolation group.

1. Patients requiring catheter ablation for persistent atrial fibrillation (AF).
2. AF ablation is performed while maintaining anticoagulation therapy.
3. Pulmonary vein isolation (PVI) is performed as the primary procedure.
4. 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.
5. Patients who fail to convert to sinus rhythm after DC cardioversion are excluded from randomization.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recurrence of atrial tachyarrhythmia
timeFrame: Within one year from the time of enrollment, excluding the first three months after the procedure
Secondary outcomes:
measure: Peri-procedural complication
timeFrame: Within one year from the time of enrollment
measure: Total procedure time
timeFrame: Periprocedural
measure: Length of hospital stay
timeFrame: Within one year from the time of enrollment
measure: patient satisfaction
timeFrame: Within one year from the time of enrollment
measure: Atrial fibrillation burden
timeFrame: Within one year from the time of enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospitoal
Study officials:
References: