Atrial Fibrillation
Conditions
Brief 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.
Detailed description
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.
Interventions
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.
PROCEDUREEmpirical 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.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure-related cardiac complication rate | 30 days after procedure | Open cardiac surgery, cerebral infarction, pericardial effusion or cardiac tamponade, hematoma in the inguinal puncture site and vascular complications |
Countries
South Korea
Outcome results
None listed