A Prospective Observational Study Evaluating the Incidence of Silent Cerebral Lesions and Procedural Safety Following Atrial Fibrillation Ablation Using the VARIPULSE™ Pulsed Field Ablation System

Study Type: Observational Study Goal: The goal of this study is to evaluate the incidence and burden of silent cerebral lesions (SCLs) detected on brain magnetic resonance imaging (MRI) after pulsed field ablation (PFA) for atrial fibrillation (AF). PFA is a new non-thermal ablation technique that selectively targets cardiac tissue while minimizing damage to surrounding structures. The study focuses on adult patients with paroxysmal or persistent AF who undergo left-atrial ablation using the VARIPULSE PFA system.

NCT Number	NCT07363278
Lead Sponsor	Seoul National University Hospital Collaborators: Biosense Webster, Inc.
Conditions	Atrial Fibrillation (AF)
Enrollment	40 participants
Start Date	2025-12-26
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-23