Investigation of Claret cerebral embolic protection device in preventing cerebral lesions during Transcatheter Aortic Valve Replacement
Recruiting
- Conditions
- Symptomatic severe Aortic Valve Stenosis (AS)Transcatheter Aortic ValveImplantation (TAVI)Cerebral infarctions (CVA)
- Registration Number
- NL-OMON22229
- Lead Sponsor
- niversity Medical center (Erasmus MC)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
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.
Exclusion Criteria
1) No written informed consent
2) Standard exclusion criteria for MRI study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Brain imaging by MRI and detection of<br /><br>o Presence of new ischemic lesions <br /><br>o Number of new ischemic lesions per patient<br /><br>o Total volume of new ischemic lesions per patient<br />
- Secondary Outcome Measures
Name Time Method Secondary endpoint<br /><br>-) Brain imaging by MRI and detection of<br>o Number of new ischemic lesions per patient<br /><br>o Total volume of new ischemic lesions per patient<br>-) 30-day Neurology endpoint: any new transient or focal neurological deficit as determined by an experienced neurologist excluding the time the patient is under influence of anesthetics.<br>-) Neurocognitive function testing<br>-) Device related complications: arterial wall damage (dissection) or thrombo-embolisation in the Claret course.