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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of silent cerebral lesions (SCLs)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Patients undergoing atrial fibrillation ablation using the Varipulse™ catheter
排除标准
- •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)
结局指标
主要结局
Incidence of silent cerebral lesions (SCLs)
时间窗: 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.
次要结局
- 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)
研究者
Eue-Keun Choi
Professor
Seoul National University Hospital