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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
150
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery
University Clinic Giessen
35392 Giessen, Hesse, Germany
RECRUITINGJohann Wolfgang Goehte University Clinic
60590 Frankfurt, Hesse, Germany
RECRUITINGKerckhoff Clinic
61231 Bad Nauheim, Hesse, Germany
RECRUITINGNeuropsychological assessment 1
Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
Time frame: 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
Time frame: 3 months (+/- 1 week) post intervention
MRI lesions detected after surgery
In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)
Time frame: 2-6 days postoperative
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