Elimination of Microemboli During Aortic Valve Replacement

Study Overview
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Brief Summary
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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.

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

Conditions
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Neurocognitive Outcome After Aortic Valve Replacement

Intervention / Treatment
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* Procedure: Embol-X intra-aortic emboli filter
* Procedure: DBT dynamic bubble trap
* Procedure: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Embol-X<br>Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery. | Procedure: Embol-X intra-aortic emboli filter<br>* Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.<br>|
| Active Comparator: DBT dynamic bubble trap<br>Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery | Procedure: DBT dynamic bubble trap<br>* Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery<br>|
| No Intervention: Control group<br>In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery | Procedure: Control group<br>* In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropsychological assessment 1 | Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures | 3 weeks to 1 day before intervention | 
| Neuropsychological assessment 2 | Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures | 3 months (+/- 1 week) post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI lesions detected after surgery | In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI) | 2-6 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Neuroprotection, Cardiopulmonary bypass, Aortic valve replacement, Micro-emboli