Aortic Valve Stenosis Clinical Trial
Official title:
Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation technique. The detection of cerebral emboli is performed not-invasively by transcranial Doppler detection of high-intensity transient signals representing solid or gaseous microembolism in the middle cerebral arteries. The investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism during aortic valve surgery using extracorporeal circulation.
Background
The gold standard to treat severe aortic valve stenosis is currently the surgical aortic
valve replacement (SAVR) using conventional extracorporeal circulation (CECC). SAVR,
however, can be performed also on minimized extracorporeal circulation (MECC), which is
characterized by reduced priming volume and interfaces between blood and artificial surfaces
and blood-air interface, respectively. Further technical developments of the MECC system
together with reports on less induction of the coagulation cascade and activation of
inflammatory systemic response may account for a reduced incidence of microbubble generation
with MECC system.
Objective
The aim of the is to investigate the procedural-related incidence of high-intensity
transient signals (HITS) representing solid or gaseous microembolism reaching the cerebral
vessels.
Methods
Patients undergoing SAVR are included in the study and randomised to either MECC or CECC
technique. HITS are continuously bilaterally detected during the entire intraoperative
period by transcranial Doppler ultrasound.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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