Status:
UNKNOWN
CLaret Embolic Protection ANd TAVI - Trial
Lead Sponsor:
University of Leipzig
Conditions:
Frequency of Cerebral Perfusion Defects After TAVI
Size of Cerebral Perfusion Defects After TAVI
Eligibility:
All Genders
18+ years
Phase:
NA
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 (TAV...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01833052
Start Date
April 1 2013
End Date
June 1 2015
Last Update
May 5 2015
Active Locations (1)
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1
Leipzig Herzzentrum
Leipzig, Germany, 04289