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
N/A
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
Researchers are evaluating the occurrence and impact of silent cerebral lesions (SCLs) detected by brain MRI after pulsed field ablation (PFA) treatment for atrial fibrillation (AF). This observational study focuses on adults with paroxysmal or persistent AF who undergo left-atrial ablation using the VARIPULSE PFA system, a new technique that uses electrical pulses to selectively target heart tissue while reducing harm to nearby areas. The study compares its findings with historical data from other ablation methods to understand neurological safety better. Participants will have brain MRI scans within 1 to 3 days after their PFA procedure to identify silent cerebral lesions. They will also complete neurological and cognitive tests assessing memory, language, and attention to detect any subtle changes. Routine clinical follow-up for AF management will continue as per standard care. This study does not include a control group but will analyze lesion characteristics such as number, size, and location on MRI. During the study, participants will undergo assessments from enrollment until three months after treatment. Researchers will measure the incidence of silent cerebral lesions and evaluate neurological complications, cognitive function, quality of life, and overall health status. The study aims to provide detailed MRI data and standardized evaluations to define the brain safety profile of PFA, supporting future improvements in AF ablation procedures.
CONDITIONS
Brief 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 Varipulse 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 requiring temporary discontinuation due to procedural complications
- Patients with a left ventricular ejection fraction 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., pacemakers, metallic implants, severe claustrophobia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 to 3 days after ablation
Participants undergo brain MRI scans shortly after the atrial fibrillation ablation to detect silent cerebral lesions and complete neurological and cognitive assessments to identify subtle functional changes.
1 visit (in-person)
Duration - Up to 3 months
Participants are observed with routine clinical follow-up for atrial fibrillation management according to standard care, including monitoring neurological complications, cognitive function, quality of life, and general health status.
Routine clinical follow-up visits as per standard care
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
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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