European Study Evaluating the EMBLOK Embolic Protection System During TAVR

Status Completed

Clinical Trial Summary

The primary objective is to evaluate the performance and the treatment effect of the use of the Emblok embolic protection system use during transcatheter aortic valve replacement with respect to procedure-related cerebral embolic burden as determined by DW-MRI.

Clinical Trial Description

The enrollment of up to thirty subjects with severe native aortic valve stenosis who meet clinically approved indications for transcatheter aortic valve replacement. The primary objective evaluates performance and treatment effect of the use of the EMBLOK. A secondary objective of this study is to analyze the safety profile and the type of captured debris from the Emblok filter after TAVR. Due to the small sample size, the study is not powered to detect a reduction in actual stroke rates. However, the potential risk of stroke will be assessed based on neurological evaluations pre and post procedure. In addition, silent ischemic damage and cerebral embolic burden will be assessed using DW MRI studies. ;

Study Design

Related Conditions & MeSH terms

Aortic Valve Disease

Clinical Trial Details

NCT number	NCT03130491
Study type	Interventional
Source	Innovative Cardiovascular Solutions
Contact
Status	Completed
Phase	N/A
Start date	March 8, 2017
Completion date	January 28, 2022

View Details

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