ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial

University of Giessen3 sites in 1 country150 target enrollmentMarch 2010

ConditionsNeurocognitive Outcome After Aortic Valve Replacement

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neurocognitive Outcome After Aortic Valve Replacement
Sponsor: University of Giessen
Enrollment: 150
Locations: 3
Primary Endpoint: Neuropsychological assessment 1
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 2010

End Date

December 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Giessen

Eligibility Criteria

Inclusion Criteria

•Age \> 18
•Elective aortic valve replacement
•Informed consent
•German language

Exclusion Criteria

•Neurological and psychiatric diseases that would conflict with neuropsychological testing (e.g. stroke, TBI, schizophrenia, etc.); further major surgeries on CPB planned for within 3 months after valve replacement
•Contraindication against MRI assessment