RecruitingNot Applicable

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

South Korea40 participantsStarted 2025-12-26

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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Exclusion criteria

✕. 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%

What they're measuring

Incidence of silent cerebral lesions (SCLs)

Timeframe: From enrollment to the end of treatment at 3 months

Trial details

NCT IDNCT07363278

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Eue-Keun Choi, MD, PhD

82-2-2072-0688 choiek417@gmail.com

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials