30
Participants
Start Date
July 31, 2012
Primary Completion Date
April 30, 2014
Study Completion Date
September 30, 2015
Intra-aortic embolic protection management system; Embol-X
"The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients embolic showers which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream."
Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen, Essen
University Hospital, Essen
OTHER