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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorEwha Womans University Mokdong Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Pulmonary Vein Isolation

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    1. 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

214 Participants
are divided into 2 treatment groups
Group A: Additional Left Atrial Posterior Wall Ablation GroupActive comparator 2 interventions
Group B: Pulmonary Vein Isolation (PVI) only GroupPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Recurrence of atrial tachyarrhythmia

Clinical recurrence rate of atrial fibrillation within one year after the procedure.

Time frame
Within one year from the time of enrollment, excluding the first three months after the procedure

Secondary outcomes

1

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

Time frame
Within one year from the time of enrollment
2

Total procedure time

total procedure time

Time frame
Periprocedural
3

Length of hospital stay

Length of hospital stay

Time frame
Within one year from the time of enrollment
4

patient satisfaction

Atrial Fibrillation Effect on Quality-of-Life(AFEQT)

Time frame
Within one year from the time of enrollment

Other outcomes

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: