CLaret Embolic Protection ANd TAVI - Trial

Not Applicable

• Conditions: Frequency of Cerebral Perfusion Defects After TAVI; Size of Cerebral Perfusion Defects After TAVI

• 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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-16
• Primary Completion: 2014-06
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-02
• Last Update Posted: 2015-05-05
• Study Completion: 2015-06

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

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).

Trial Locations

Locations (1)

Leipzig Herzzentrum; 🇩🇪 Leipzig, Germany