Frequency of Cerebral Perfusion Defects After TAVI, Size of Cerebral Perfusion Defects After TAVI
Conditions
Brief summary
This prospective, randomized study was designed to investigate the benefit of using a Filter-Protection-Device (Claret MontageTM Dual Filter System) during transcatheter aortic valve implantation (TAVI) with a Medtronic CoreValve®.
Interventions
DEVICETAVI (Medtronic CoreValve)
DEVICEClaret-Filter
Sponsors
University of Leipzig
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be scheduled to undergo an endovascular aortic valve prosthesis (Medtronic CoreValve®) implant procedure with the femoral artery as the intended access site for the valve delivery system.
Exclusion criteria
* Patient is unsuitable for TAVI * Prior Stroke or TIA in the last 12 month * Carotic stenosis \>70% * Relevant stenosis of the brachiocephalic trunc or the right subclavian artery * Expected Non-compliance for follow-ups * Pregnancy * Patient is already recruited for another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate and Size of Cerebral Embolism | 2 days after Intervention | Primary endpoint ist the rate and the size of cerebral embolism in postinterventional Magnetic Resonance Imaging (MRI). |
Countries
Germany
Outcome results
None listed