Checks brain scans for silent lesions after heart rhythm ablation
Observes brain changes on MRI in adults with atrial fibrillation after pulsed field ablation.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Seoul, South KoreaSee the site
Where in South Korea
- Seoul National Universtiy Hospital, SeoulSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seoul National University Hospital
- Trial code
- NCT07363278
- Record updated
- 23 January 2026
- Original description
Study Type: Observational StudyRead full original descriptionShow less
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
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.
Inclusion: Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter.
Exclusion: Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure; Patients who have previously undergone ablation or surgery for atrial fibrillation; Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia); Patients with a history of stroke or transient ischemic attack (TIA); Patients who have experienced cardiac surgery or acute coronary syndrome within the past 90 days; Patients with contraindications to oral anticoagulant therapy, or those who require temporary discontinuation of anticoagulation due to procedural complications (e.g., cardiac tamponade); Patients with a left ventricular ejection fraction (LVEF) of less than 35%; Individuals under 19 years of age; Patients with intracardiac thrombus or embolic events within the past 90 days; Women who are currently pregnant or planning to become pregnant during the study period; Patients with a life expectancy of less than one year.