A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 试验地点
- 2
- 主要终点
- Change in high sensitivity CRP (hs-CRP)
研究概览
简要总结
Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.
详细描述
Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
For both the parent study and the sub-study, participants and investigators will be unblinded.
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
- •Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included
排除标准
- •Severe peripheral arterial disease that precludes deployment of Sentinel device
- •Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device
- •Unable or unwilling to provide informed consent.
- •Known history of dementia.
结局指标
主要结局
Change in high sensitivity CRP (hs-CRP)
时间窗: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation
Change in NT-proBNP
时间窗: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
NT-proBNP measured in pg/ml to detect changes in tissue damage
New cerebral infarcts
时间窗: day 1 to 7 after atrial fibrillation ablation
Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group
Change in interleukin-6 (IL-6)
时间窗: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation
Change in high sensitivity troponin
时间窗: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
High sensitivity troponin measure in ng/mL to detect changes in tissue damage
次要结局
未报告次要终点
研究者
Ammar M. Killu
Principal Investigator
Mayo Clinic