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Investigation of Claret cerebral embolic protection device in preventing cerebral lesions during Transcatheter Aortic Valve Replacement


- candidate number15552
- NTR NumberNTR4236
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-okt-2013
- Secondary IDsNL 40999.078.12 17-02-2013
- Public TitleInvestigation of Claret cerebral embolic protection device in preventing cerebral lesions during Transcatheter Aortic Valve Replacement
- Scientific TitleMRI Investigation in Transcatheter Aortic Valve replacement with Claret
- ACRONYMMISTRAL-C
- hypothesisThe use of the Claret device in TAVI procedures reduces the incidence of ischemic cerebral lesions (detected by DW-MRI)
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1) 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 criteria1) No written informed consent
2) Standard exclusion criteria for MRI study
3) Transfemoral access not possible
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) Significant common carotid artery stenosis (> 70%) by MSCT scan
8) Not native Dutch speaking
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- control[default]
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-jan-2013
- planned closingdate31-dec-2014
- Target number of participants54
- InterventionsThe Claret device is an Embolic Protection Device consisting of two nitinol baskets to be introduced through the right radial artery. One basket is positioned in the brachiocephalic trunk, the other in the left common carotid artery.
- Primary outcomeBrain imaging by MRI and detection of
o Presence of new ischemic lesions
o Number of new ischemic lesions per patient
o Total volume of new ischemic lesions per patient
- Secondary outcomeSecondary endpoint
-) Brain imaging by MRI and detection of o Number of new ischemic lesions per patient
o Total volume of new ischemic lesions per patient -) 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. -) Neurocognitive function testing -) Device related complications: arterial wall damage (dissection) or thrombo-embolisation in the Claret course.
- Timepointsstudy duration for patients is a MRI at 3 days postprocedure, routine follow-up at 30 days, and MRI at 6 month
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD N. Mieghem, van
- CONTACT for SCIENTIFIC QUERIESMD N. Mieghem, van
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center
- PublicationsN/A
- Brief summaryThe TAVI experience is rapidly mounting worldwide. DW-MRI detects subclinical new ischemic cerebral lesions after TAVI in the majority of cases. Although the immediate clinical impact seems negligible, the implications on the longer term are unknown. These subclinical cerebral lesions may play a role in neurocognitive deterioration. If the use of the Claret device in TAVI procedures may reduce the incidence of these cerebral lesions this may have considerable clinical significance in the long run. Patients who are participating in this study may potentially have a significant clinical benefit.
- Main changes (audit trail)
- RECORD14-okt-2013 - 18-dec-2013


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