NL-OMON39581
Completed
N/A
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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- cerebral embolism
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 54
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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