No registrations found.
ID
Source
Brief title
Health condition
Symptomatic severe Aortic Valve Stenosis (AS)
Transcatheter Aortic Valve
Implantation (TAVI)
Cerebral infarctions (CVA)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Brain 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 outcome
Secondary 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.
Background summary
The 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.
Study objective
The use of the Claret device in TAVI procedures reduces the incidence of ischemic cerebral lesions (detected by DW-MRI)
Study design
study duration for patients is a MRI at 3 days postprocedure, routine follow-up at 30 days, and MRI at 6 month
Intervention
The 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.
dept Intervention Cardiology
PO Box 2040
N. Mieghem, van
Rotterdam 3000 CA
The Netherlands
n.vanmieghem@erasmusmc.nl
dept Intervention Cardiology
PO Box 2040
N. Mieghem, van
Rotterdam 3000 CA
The Netherlands
n.vanmieghem@erasmusmc.nl
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
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4092 |
| NTR-old | NTR4236 |
| CCMO | NL40999.078.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39581 |