Cerebral Safety After Pulsed-Field Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- ischaemic lesion
研究概览
简要总结
A study evaluating the incidence of ischaemic lesions detected by brain MRI scan in subjects undergoing pulsed-field ablation for atrial fibrillation (VARIPULSE system).
详细描述
An observational study evaluating the incidence of ischaemic lesions on brain MRI performed after ablation of atrial fibrillation using the Varipulse catheter.
- A baseline MRI scan will be carried out one day before the procedure.
- A post-procedure MRI scan will be performed 24-36 hours after the procedure.
- A follow-up MRI will be performed within 1 year after the ablation.
Paroxysmal and non-paroxysmal AF patients will be included. Regarding the extent of ablation lesions, pulmonary vein isolation (PVI) will be performed in paroxysmal AF, whereas PVI + left atrial posterior wall ablation will be performed in non-paroxysmal patients. All procedures will be performed under intracardiac echocardiography guidance.
The patients will undergo a neurocognitive evaluation:
- One day before the procedure: Montreal Cognitive Assessment (The MoCA Test)
- 24-36 hours after the procedure: The National Institutes of Health Stroke Scale (NIHSS)
- Up to 1 year after the procedure the MoCA test.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •AF with an indication for ablation
排除标准
- •MRI contraindication
结局指标
主要结局
ischaemic lesion
时间窗: one day before the procedure (the first MRI scan), 24-36 hour sfter the procedure (the second scan) and up to 1 year after the procedure (the third scan)
ischemic lesion on MRI
次要结局
- Neurocognitive evaluation(one day before the procedure (the first MoCA test) and up to 1 year after the procedure (the second MoCA test))
- NIHSS score(24-36 hours after the procedure)
研究者
Marek Hozman, MD, PhD
Interventional electrophysiologist
Charles University, Czech Republic