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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

Recruitingn/aAges 19 Years - anyAllSeoul National University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1\) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter Exclusion Criteria: 1. Individuals under 19 years of age 2. Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure 3. Patients with a history of stroke or transient ischemic attack (TIA) 4. Patients who have previously undergone ablation or surgery for atrial fibrillation 5. Patients with intracardiac thrombus or embolic events within the past 90 days 6. Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days 7. Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade) 8. Patients with a left ventricular ejection fraction (LVEF) of less than 35% 9. Women who are currently pregnant or planning to become pregnant during the study period 10. Patients with a life expectancy of less than one year 11. Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)
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What it tests

  • Not listed
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Where

1 site
Seoul National Universtiy Hospital, Seoul
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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