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
Condition(s) studied
Study 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
Primary outcome measure(s)
- Incidence of silent cerebral lesions (SCLs) — From enrollment to the end of treatment at 3 months
The proportion of patients in whom silent cerebral lesions (SCLs) are detected on brain MRI performed within 72 hours after atrial fibrillation ablation using the VARIPULSE PFA catheter. Definition of SCL: A lesion that shows positive findings on both diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Seoul National Universtiy Hospital, Seoul | Seoul | Jongro-ku | Recruiting |
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07363278 on ClinicalTrials.gov ↗ ← All trials in South Korea