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
- Conditions
- cerebral embolismstroke10046973
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 54
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint<br /><br><br /><br>- Incidence, number and volume of new cerebral ischemic lesions as detected by<br /><br>DW -MRI post TAVI.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br><br /><br>• 30-day Neurology endpoint: any new transient or persisting focal neurological<br /><br>deficit as determined by an experienced neurologist excluding the time the<br /><br>patient is under influence of anesthetics.<br /><br>• Changes in Neurocognitive function at 3 months follow up<br /><br>• 30 day mortality<br /><br>• Device related bleeding and vascular complications.<br /><br>• Histlogic examination of debris captured by the Claret Device</p><br>