Overview

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

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®.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Other)
Patient is treated with Cerebral protection Filter.
tavi (medtronic corevalve)
claret-filter
(Other)
Patient is not treated with Cerebral protection Filter.
tavi (medtronic corevalve)

Primary Outcomes

Measure
Rate and Size of Cerebral Embolism
time frame: 2 days after Intervention

Eligibility Criteria

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

Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Leipzig.