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| Name | Class |
|---|---|
| Else Kröner Fresenius Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embol-X | Active Comparator | Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery. |
|
| DBT dynamic bubble trap | Active Comparator | Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery |
|
| Control group | No Intervention | In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embol-X intra-aortic emboli filter | Procedure | Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niko Schwarz, PhD | Contact | +49(0)6032/999- | 5811 | niko.schwarz@neuro.med.uni-giessen.de |
| Tibo Gerriets, MD | Contact | +40(0)6032/999- | 5812 | tibo.gerriets@neuro.med.uni-giessen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Clinic Giessen | Recruiting | 35392 Giessen | Hesse | 35392 | Germany |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| DBT dynamic bubble trap | Procedure | Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery |
|
| Control group | Procedure | In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery |
|
| Johann Wolfgang Goehte University Clinic | Recruiting | 60590 Frankfurt | Hesse | 60590 | Germany |
|
| Kerckhoff Clinic | Recruiting | 61231 Bad Nauheim | Hesse | 61231 | Germany |
|
| D008722 | Methods |