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This is a prospective, multicenter, randomized controlled trial comparing CT-guided versus empirical pulsed field ablation (PFA) for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. The study investigates whether atrial wall thickness-based energy titration improves arrhythmia outcomes compared to standard empirical ablation using the PulseSelectâ„¢ system.
Pulmonary vein isolation (PVI) using pulsed field ablation (PFA) is an effective and increasingly adopted strategy for the treatment of paroxysmal atrial fibrillation (AF). However, current empirical lesion protocols do not account for patient-specific anatomical variability, particularly atrial wall thickness, which may influence lesion durability. This randomized controlled trial aims to evaluate whether a CT-guided ablation strategy-using pre-procedural atrial wall thickness maps to titrate lesion application-can improve rhythm outcomes compared to standard empirical PFA. A total of 298 patients will be enrolled and randomized to either the CT-guided or empirical group, with follow-up over 12 months to assess freedom from atrial arrhythmia recurrence and procedure-related safety outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT myocardial thickness map guided PV isolation group | Experimental |
| |
| Empirical PV isolation group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT myocardial thickness map guided PV isolation group | Procedure | Pulmonary vein isolation will be performed using the PulseSelectâ„¢ pulsed field ablation system. A pre-procedural cardiac CT scan will be used to generate an atrial myocardial thickness map. In this group, atrial segments with wall thickness >2.5 mm identified on the CT map will receive additional PFA applications (up to 8 per PV) to ensure transmural lesion formation. All other segments will receive the standard minimum of 8 applications per vein. The ablation catheter will remain stationary to allow lesion stacking when needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial arrhythmia recurrence | Any documented episode of AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period. | Within 1 year after 3 months of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related cardiac complication rate | Open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications | 30 days after procedure |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | 120-752 | South Korea |
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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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| Empirical PV isolation group | Procedure | Pulmonary vein isolation will be performed using the PulseSelectâ„¢ pulsed field ablation system according to a standardized empirical protocol. Each pulmonary vein will receive a minimum of 8 PFA applications without adjustment based on anatomical or CT-based parameters. Additional applications may be delivered at the operator's discretion based on procedural findings, but no wall thickness mapping will be used. |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |