NL-OMON39581已完成不适用
MRI Investigation in Transcatheter Aortic Valve replacement with Claret: a randomized study to assess by MRI the reduction in cerebral embolic lesions during Transcatheter Aortic Valve Replacement with the Claret embolic protection device - MISTRAL-C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1) Patients with severe AS at high operative risk who will undergo planned TAVI
- •2) Informed consent to participate in the study (i.e. use of Claret device yes or no) and undergo DW -MRI before and after the procedure.
- •3) Compatible left common carotid artery (>= 5 mm) and brachiocephalic artery (>= 9 mm)
- •diameters without significant stenosis (> 70%) as determined by Multi-Slice Computed
- •Tomography (MSCT) scan
排除标准
- •1) No written informed consent
- •2) Standard exclusion criteria for MRI study (see Appendix 4)
- •3) Anatomical exclusion for filter deployment
- •4) Permanent Pacemaker/AICD in situ before TAVI
- •5) Planned implantation of a pacemaker implantation after TAVI.
- •6) Previous stroke with residual neurological symptoms or dementia
- •7) Not native Dutch speaking
研究者
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