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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Incidence of silent cerebral lesions (SCLs)
Study Overview
Brief Summary
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.
Detailed Description
Main Questions the Study Aims to Answer:
What percentage of patients develop silent cerebral lesions after PFA using the VARIPULSE system?
What are the lesion characteristics (number, size, and location) and total lesion burden on MRI?
Are there any early neurological or cognitive changes related to these MRI findings?
Comparison:
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1) 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)
Outcomes
Primary Outcomes
Incidence of silent cerebral lesions (SCLs)
Time Frame: From enrollment to the end of treatment at 3 months
The proportion of patients in whom silent cerebral lesions (SCLs) are detected on brain MRI performed within 72 hours after atrial fibrillation ablation using the VARIPULSE PFA catheter. Definition of SCL: A lesion that shows positive findings on both diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences.
Secondary Outcomes
- Number and total volume (mm³) of silent cerebral lesions (SCLs) in patients with positive SCL findings after the procedure.(From enrollment to the end of treatment at 3 months)
- Neurological complications(From enrollment to the end of treatment at 3 months)
- Cognitive function(From enrollment to the end of treatment at 3 months)
- Quality of Life (QoL)(From enrollment to the end of treatment at 3 months)
- General health status(From enrollment to the end of treatment at 3 months)
Investigators
Eue-Keun Choi
Professor
Seoul National University Hospital