Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

September 30, 2015

Conditions
Transaortic Transcatheter Aortic Valve Implantation
Interventions
DEVICE

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."

Trial Locations (1)

45122

Department of Thoracic and Cardiovascular Surgery, West-German Heart Center Essen, University Duisburg-Essen, Essen

All Listed Sponsors
lead

University Hospital, Essen

OTHER

NCT01735513 - Intraprocedural Intraaortic Embolic Protection With the EmbolX Device in Patients Undergoing Transaortic Transcatheter Aortic Valve Implantation | Biotech Hunter | Biotech Hunter