Ireland
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Recruiting Observational

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

NCT07363278 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2025-12-26
Last updated
2026-01-23

Condition(s) studied

Atrial Fibrillation (AF)

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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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)

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)

FacilityCityRegionStatus
Seoul National Universtiy Hospital, Seoul Seoul Jongro-ku Recruiting
Official registry record

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