About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Pulmonary Vein Isolation
Procedure/Surgery1. 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
Procedure/Surgery1. 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
Procedure/Surgery1. If atrial fibrillation triggers are identified with isoproterenol infusion, additional focal ablation is performed. 2. Post-procedural rhythm monitoring follows the study protocol.
Treatment groups
Trial outcomes
Primary outcomes
Recurrence of atrial tachyarrhythmia
Clinical recurrence rate of atrial fibrillation within one year after the procedure.
Secondary outcomes
Peri-procedural complication
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
total procedure time
Length of hospital stay
Length of hospital stay
patient satisfaction
Atrial Fibrillation Effect on Quality-of-Life(AFEQT)
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ewha Womans University Mokdong Hospital
Lead sponsor
Ewha Womans University Seoul Hospital
Collaborator
Korea University Anam Hospital
Collaborator
Ajou University School of Medicine
Collaborator
Seoul National University Bundang Hospital
Collaborator
Kangbuk Samsung Hospital
Collaborator
Hanyang University Seoul Hospital
Collaborator
Asan Medical Center
Collaborator
Wonkwang University Hospital
Collaborator
Korea University Guro Hospital
Collaborator
Severance Hospital
Collaborator
Eunpyeong St. Mary's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: