CT myocardial thickness map guided PV isolation group: Pulmonary vein isolation will be performed using the PulseSelect™ 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.
Empirical PV isolation group: Pulmonary vein isolation will be performed using the PulseSelect™ 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.
Study summary
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 PulseSelect™ system.
Eligibility
Sex
ALL
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
* Patient with paroxysmal atrial fibrillation who is scheduled for ablation procedure and ≥19 and ≤80 years of age
* Left atrium size \< 50mm
* paroxysmal atrial fibrillation that is recurrence during antiarrhythmic drug treatment or is not able to use an antiarrhythmic drug.
* Patient who is indicated for anticoagulation therapy (for prevention of cerebral infarction)
Exclusion Criteria:
* Patients with persistent or permanent atrial fibrillation
* Atrial fibrillation associated with severe cardiac malformation or a structural heart disease that is hemodynamically affected
* Patients with severe renal impairment or CT imaging difficulty using contrast media
* Patients with a past history of radiofrequency ablation for atrial fibrillation or other cardiac surgery
* Patients with active internal bleeding
* Patients with contraindications for anticoagulation therapy(for prevention of cerebral infarction) and antiarrhythmic drugs
* Patients with valvular atrial fibrillation (mitral stenosis \>grade 2, mechanical valve, mitral valvuloplasty)
* Patients with a severe comorbid disease
* Expected survival \< 1 year
* Drug addicts or alcoholics
* Patients who cannot read the consent form (illiterates, foreigners, etc.)
* Other patients who are judged by the principal or sub-investigator to be ineligible for participation in this clinical study
Primary outcome measure(s)
Freedom from atrial arrhythmia recurrence — Within 1 year after 3 months of procedure Any documented episode of AF, atrial flutter, or atrial tachycardia lasting ≥30 seconds after a 3-month blanking period.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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