Atrial Fibrillation (AF)
Conditions
Keywords
pulsed field ablation, catheter ablation, posterior wall isolation, atrial fibrillation
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 is a major cardiovascular disease, and catheter ablation has become an established rhythm-control strategy that provides superior outcomes compared with pharmacological therapy in patients with drug-refractory atrial fibrillation. Although the efficacy of pulmonary vein isolation (PVI) is well established in patients with paroxysmal atrial fibrillation, the effectiveness of additional ablation strategies beyond PVI remains uncertain in patients with persistent atrial fibrillation. Several studies have suggested that left atrial posterior wall isolation (PWI) may help reduce recurrence; however, conventional thermal ablation techniques have been limited by technical challenges in achieving durable lesion formation. Pulsed field ablation (PFA) is a nonthermal ablation technology that creates selective myocardial lesions, enabling rapid and consistent lesion formation while minimizing injury to surrounding tissues. This study aims to prospectively and randomly compare PVI alone using PFA with PVI followed by additional PWI in patients with persistent atrial fibrillation. By evaluating recurrence rates, procedure time, complications, atrial fibrillation burden, and patient satisfaction, this study seeks to identify the optimal ablation strategy for patients with persistent atrial fibrillation.
Interventions
PROCEDUREPulmonary 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.
PROCEDUREAdditional 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.
PROCEDURENon-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.
Sponsors
Ewha Womans University Mokdong Hospital
Ewha Womans University Seoul Hospital
Korea University Anam Hospital
Kangbuk Samsung Hospital
Asan Medical Center
Severance Hospital
Samsung Medical Center
Chonnam National University Hospital
Daegu Catholic University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
1. Pulmonary vein isolation (PVI) is performed using pulsed-field ablation. After the procedure, electrical cardioversion is performed, and patients successfully converted to sinus rhythm are randomly assigned in a 1:1 ratio to either the PVI-only group or the PVI with additional left atrial posterior wall isolation group. 2. Patients who fail to convert to sinus rhythm after electrical cardioversion are excluded from randomization. 3. The target sample size is 482 patients, with 241 patients in each group. 4. Rhythm follow-up is performed at baseline, 3 months, 6 months, and 12 months using Holter monitoring or single-lead wearable ECG together with 12-lead ECG, with additional assessments when clinically indicated. 5. Outcomes include comparison of atrial tachyarrhythmia recurrence, procedural complications, procedure time, AF burden, and patient-reported satisfaction (AFEQT) between groups.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 20 to 80 years who are candidates for catheter ablation for persistent atrial fibrillation * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of atrial tachyarrhythmia | Within 12 months after the procedure, excluding the first 4-week blanking period | Freedom from documented AF/AT/AFL ≥30 seconds at 12 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-procedural complication | Within 12 months after the procedure | 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 | Periprocedural | total procedure time |
| Length of hospital stay | Within one year from the time of enrollment | Length of hospital stay |
| Atrial fibrillation burden assessed by Holter ECG | Within 12 month from the time of enrollment | Atrial fibrillation burden will be calculated as the percentage of the total analyzable Holter ECG monitoring time spent in atrial fibrillation or atrial tachyarrhythmia. Values range from 0% to 100%, with higher percentages indicating a greater atrial fibrillation burden and therefore a worse outcome. |
| patient satisfaction | Within one year from the time of enrollment | Atrial Fibrillation Effect on Quality-of-Life(AFEQT) |
Countries
South Korea
Outcome results
None listed