CLaret Embolic Protection ANd TAVI - Trial
Not Applicable
- Conditions
- Frequency of Cerebral Perfusion Defects After TAVISize of Cerebral Perfusion Defects After TAVI
- Interventions
- Device: TAVI (Medtronic CoreValve)Device: Claret-Filter
- Registration Number
- NCT01833052
- Lead Sponsor
- University of Leipzig
- 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®.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cerebral Protection Filter Claret-Filter Patient is treated with Cerebral protection Filter. Cerebral Protection Filter TAVI (Medtronic CoreValve) Patient is treated with Cerebral protection Filter. No Cerebral Protection Filter TAVI (Medtronic CoreValve) Patient is not treated with Cerebral protection Filter.
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Leipzig Herzzentrum
🇩🇪Leipzig, Germany