The use of the Claret device in TAVI procedures reduces the incidence of ischemic cerebral lesions (detected by DW-MRI)
ID
Bron
Verkorte titel
Aandoening
Symptomatic severe Aortic Valve Stenosis (AS)
Transcatheter Aortic Valve
Implantation (TAVI)
Cerebral infarctions (CVA)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Brain imaging by MRI and detection of<br>
o Presence of new ischemic lesions <br>
o Number of new ischemic lesions per patient<br>
o Total volume of new ischemic lesions per patient<br>
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The use of the Claret device in TAVI procedures reduces the incidence of ischemic cerebral lesions (detected by DW-MRI)
Onderzoeksopzet
study duration for patients is a MRI at 3 days postprocedure, routine follow-up at 30 days, and MRI at 6 month
Onderzoeksproduct en/of interventie
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.
Publiek
dept Intervention Cardiology
PO Box 2040
N. Mieghem, van
Rotterdam 3000 CA
The Netherlands
n.vanmieghem@erasmusmc.nl
Wetenschappelijk
dept Intervention Cardiology
PO Box 2040
N. Mieghem, van
Rotterdam 3000 CA
The Netherlands
n.vanmieghem@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4092 |
| NTR-old | NTR4236 |
| CCMO | NL40999.078.12 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON39581 |