Actively Recruiting
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
Led by Seoul National University Hospital · Updated on 2026-01-23
40
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
B
Biosense Webster, Inc.
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing atrial fibrillation ablation using the Varipulse2 catheter
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National Universtiy Hospital, Seoul
Seoul, Jongro-ku, South Korea, 03080
Actively Recruiting
Research Team
E
Eue-Keun Choi, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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