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| Name | Class |
|---|---|
| Ewha Womans University Seoul Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| Ajou University School of Medicine | OTHER |
| Seoul National University Bundang Hospital |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional Left Atrial Posterior Wall Ablation Group | Active Comparator | After pulmonary vein isolation, electrical isolation of the left atrial posterior wall is performed using a pulsed-field ablation catheter with EGM-guided ablation. |
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| Pulmonary Vein Isolation (PVI) only Group | Placebo Comparator | Electrical isolation of all four pulmonary veins is performed using a pulsed-field ablation catheter. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Vein Isolation | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrence of atrial tachyarrhythmia | Clinical recurrence rate of atrial fibrillation within one year after the procedure. | Within one year from the time of enrollment, excluding the first three months after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within one year from the time of enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junbeom Park, M.D., Ph.D. | Contact | +82-02-2650-5826 | newriser@naver.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ewha Womans University Mokdong Hospitoal | Seoul | South Korea |
Individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and the lack of specific consent for data sharing obtained during the study enrollment process.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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 |
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.
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| Additional Left Atrial Posterior Wall Ablation | Procedure |
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| Non-PV trigger test | Procedure |
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| Total procedure time | total procedure time | Periprocedural |
| Length of hospital stay | Length of hospital stay | Within one year from the time of enrollment |
| patient satisfaction | Atrial Fibrillation Effect on Quality-of-Life(AFEQT) | Within one year from the time of enrollment |
| Atrial fibrillation burden | Atrial fibrillation burden (%) recorded via holter ECG | Within one year from the time of enrollment |
| D013568 |
| Pathological Conditions, Signs and Symptoms |