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Elimination of Microemboli During Aortic Valve Replacement

2014-07-23 21:09:00 | BioPortfolio

Summary

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Neurocognitive Outcome After Aortic Valve Replacement

Intervention

Embol-X intra-aortic emboli filter, DBT dynamic bubble trap, Control group

Location

University Clinic Giessen
35392 Giessen
Hessen
Germany
35392

Status

Recruiting

Source

University of Giessen

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:00-0400

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