Evaluate Reduction in Asymptomatic Cerebral Embolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 8
- 主要终点
- New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.
研究概览
简要总结
The purpose of the study is to determine the rate of diffusion weighted (DW)-MRI cerebral lesions following a Pulmonary Vein Ablation Catheter (PVAC) ablation procedure performed using best practices, including optimized procedural techniques and anti-coagulation therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is at least 18 years old
- •Subject has been diagnosed with atrial fibrillation (AF)
- •Subject is indicated for a pulmonary vein ablation using PVAC
- •Subject (or subject's legally authorized representative) is able and and willing to give informed consent.
排除标准
- •Subject has permanent AF
- •Subject has a left atrial thrombus detected on TEE
- •Subject has had a prior left atrial ablation
- •Subject has a intracardiac thrombus
- •Subject is contraindicated for Warfarin (Coumadin)
- •Subject has a cardiac valve prosthesis
- •Subject has a significant congenital heart defect corrected or not including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- •Subject has presence of any pulmonary vein stents
- •Subject has presence of any pre-existing pulmonary vein stenosis
- •Subject has had a cerebral ischemic event (strokes or transient ischemic attacks [TIA]) which occurred during the 6 month interval preceding the Consent Date
- •Subject is a woman known to be pregnant
- •Subject is unwilling or unable to comply fully with study procedures and follow-up
研究组 & 干预措施
Ablation
干预措施: Magnetic Resonance Imaging (MRI) (Other)
结局指标
主要结局
New Asymptomatic Cerebral Embolic Lesions, Visualized as 'Bright Spots' on Post-ablation MRI.
时间窗: Within 1-3 days post ablation
An acute embolic lesion is defined as a focal hyper-intense area detected on the diffusion-weighted (DW) sequence, corresponding to a hyper-intense signal intensity in the fluid-attenuated inversion recovery (FLAIR) sequence, and also confirmed by apparent diffusion coefficient (ADC) mapping to rule out a shine-through artifact.
次要结局
- Acute Safety Events(30 days)
- Acute Efficacy, as Determined by Complete Pulmonary Vein Isolation (PVI) Per Subject.(Day 1 (End of Procedure))