Neurocognitive Outcome After Aortic Valve Replacement Clinical Trial
Official title:
ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial
In a randomized controlled trial patients undergoing aortic valve replacement are recruited into 3 groups. Patients receive either an intra-aortic filter (Embol-X), designed to reduce solid microemboli during mechanical surgical intervention, a dynamic bubble-trap (DBT), designed to reduce gaseous microemboli from cardiopulmonary bypass (CPB), or no additional device (control-group). Cognitive functioning is assessed 3 weeks to 1 day before and 3 months (+/- 1 week) after valve replacement. Furthermore, cerebral magnetic resonance imaging (MRI) is carried 2-6 days after surgery. Primary endpoint is the cognitive outcome of the filter groups compared to the controls. Secondary endpoint is the number of acute ischemic lesions after CABG.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention