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

Sponsored by Seoul National University Hospital

About this trial

Last updated 4 months ago

Study ID

VARIACE study

Status

Recruiting

Type

Observational

Placebo

Accepting

19+ Years

All Sexes

Trial Timing

Started 5 months ago

What is this trial about?

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.

What are the participation requirements?

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)