Neurocognitive Outcome After Aortic Valve Replacement
Conditions
Keywords
Cognition, Neuroprotection, Cardiopulmonary bypass, Aortic valve replacement, Micro-emboli
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.
Interventions
PROCEDUREEmbol-X intra-aortic emboli filter
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
PROCEDUREDBT dynamic bubble trap
Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
PROCEDUREControl group
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery
Sponsors
Else Kröner Fresenius Foundation
University of Giessen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuropsychological assessment 1 | 3 weeks to 1 day before intervention | Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures |
| Neuropsychological assessment 2 | 3 months (+/- 1 week) post intervention | Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI lesions detected after surgery | 2-6 days postoperative | In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI) |
Countries
Germany
Contacts
Primary ContactNiko Schwarz, PhD
Backup ContactTibo Gerriets, MD
Outcome results
None listed