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Thickness Map-Guided vs. Empirical PV Isolation Using Pulsed Field Ablation for Paroxysmal AF
Sponsor: Yonsei University
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.
Official title: Computed Tomogram Myocardial Thickness Map-Guided Pulmonary Vein Isolation vs. Empirical Pulmonary Vein Isolation in Pulse-Field Ablation for Paroxysmal Atrial Fibrillation (UTMOST AF III)
Key Details
Gender
All
Age Range
19 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
298
Start Date
2025-08
Completion Date
2029-07-31
Last Updated
2025-07-16
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Severance Hospital
Seoul, South Korea