RecruitingNCT07363278

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

Sponsor

Seoul National University Hospital

Enrollment

40 participants

Start Date

Dec 26, 2025

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation (AF)

Summary

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria1

\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter

Exclusion Criteria11

Individuals under 19 years of age
Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure
Patients with a history of stroke or transient ischemic attack (TIA)
Patients who have previously undergone ablation or surgery for atrial fibrillation
Patients with intracardiac thrombus or embolic events within the past 90 days
Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days
Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade)
Patients with a left ventricular ejection fraction (LVEF) of less than 35%
Women who are currently pregnant or planning to become pregnant during the study period
Patients with a life expectancy of less than one year
Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)