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
Recruiting · NCT07363278 · Observational (researchers observe without assigning treatment) · Lead sponsor: Seoul National University Hospital
View the official record on ClinicalTrials.gov →What this trial is 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.
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- \) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter
Exclusion criteria
- Individuals under 19 years of age
- Patients who undergo concomitant radiofrequency ablation of the left atrium during the procedure
- Patients with a history of stroke or transient ischemic attack (TIA)
- Patients who have previously undergone ablation or surgery for atrial fibrillation
- Patients with intracardiac thrombus or embolic events within the past 90 days
- 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%
- Women who are currently pregnant or planning to become pregnant during the study period
- Patients with a life expectancy of less than one year
- Patients at increased risk during MRI scanning (e.g., those with pacemakers or other metallic implants affected by MRI, or those with severe claustrophobia)
Where it is running
1 location listed.
- Seoul National Universtiy Hospital, Seoul - Seoul, Jongro-ku, South Korea