CLaret Embolic Protection ANd TAVI - Trial
This trial is active, not recruiting.
|Conditions||frequency of cerebral perfusion defects after tavi, size of cerebral perfusion defects after tavi|
|Treatments||tavi (medtronic corevalve), claret-filter|
|Sponsor||University of Leipzig|
|Start date||April 2013|
|End date||June 2014|
|Trial size||100 participants|
|Trial identifier||NCT01833052, HZL-01-TAVI|
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®.
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||supportive care|
Patient is treated with Cerebral protection Filter.
Patient is not treated with Cerebral protection Filter.
Rate and Size of Cerebral Embolism
time frame: 2 days after Intervention
Male or female participants at least 18 years old.
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
Call for more information