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

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

Plain Language Summary

Simplified for easier understanding

This study is tracking how often small, silent brain lesions (tiny areas of brain injury that cause no symptoms) occur after a heart rhythm procedure called atrial fibrillation ablation using a new device called the VARIPULSE Pulsed Field Ablation System. Doctors want to make sure this newer procedure is as safe as older methods. **You may be eligible if...** - You are having atrial fibrillation (irregular heartbeat) ablation using the VARIPULSE catheter device - You are 19 years or older **You may NOT be eligible if...** - You have a history of stroke or TIA (mini-stroke) - You have previously had surgery or ablation on your heart for atrial fibrillation - There is a blood clot in your heart or you have had a clot-related event in the past 90 days - You had heart surgery or a heart attack in the past 90 days - You cannot safely take blood thinners - You have a pacemaker or other implanted cardiac device - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Seoul National Universtiy Hospital, Seoul

Seoul, Jongro-ku, South Korea

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NCT07363278


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