PVI Alone vs PVI With Posterior Wall Isolation for Pulse-Field Ablation in Persistent AF
NCT ID: NCT06929897
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
214 participants
INTERVENTIONAL
2025-05-01
2027-10-01
Brief Summary
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\- 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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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Additional Left Atrial Posterior Wall Ablation Group
After pulmonary vein isolation, electrical isolation of the left atrial posterior wall is performed using a pulsed-field ablation catheter with EGM-guided ablation.
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.
Pulmonary Vein Isolation (PVI) only Group
Electrical isolation of all four pulmonary veins is performed using a pulsed-field ablation catheter.
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Those without clinically significant structural heart disease (e.g., severe mitral regurgitation)
* Those without contraindications to anticoagulation therapy
Exclusion Criteria
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Ewha Womans University Seoul Hospital
OTHER
Korea University Anam Hospital
OTHER
Ajou University School of Medicine
OTHER
Seoul National University Bundang Hospital
OTHER
Kangbuk Samsung Hospital
OTHER
Hanyang University Seoul Hospital
OTHER
Asan Medical Center
OTHER
Wonkwang University Hospital
OTHER
Korea University Guro Hospital
OTHER
Severance Hospital
OTHER
Eunpyeong St. Mary's Hospital
OTHER
Ewha Womans University Mokdong Hospital
OTHER
Responsible Party
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Locations
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Ewha Womans University Mokdong Hospitoal
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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POBI-PFA
Identifier Type: -
Identifier Source: org_study_id
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