Aortic Valve Stenosis Clinical Trial
— AKE-MECCOfficial title:
Aortic Valve Replacement Using Closed Extracorporeal Circuit. Minimized Versus Conventional Extracorporeal Circulation Technique: Qualitative Differences
Verified date | June 2016 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 48 |
Est. completion date | June 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Isolated Severe Aortic Valve Stenosis - No other cardiac disease - No other coronary heart disease - Written informed consent Exclusion Criteria - Double valve surgery - Concomitant coronary artery bypass surgery - Vascular surgery - Age < 18 yrs. - Age > 80 yrs. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total and interval-related cerebral microembolic load as measured by transcranial Doppler | Intraoperative period (start surgical procedure to skin suture, duration approx. 4 hrs) | No | |
Secondary | Cerebral complications, e.g. delirium and stroke as detected clinically | In-hospital period (until hospital discharge, duration approx. 7-10 days) | No | |
Secondary | Redo surgery | In-hospital period (until hospital discharge, duration approx. 7-10 days) | No | |
Secondary | ICU length of stay | In-hospital period (until hospital discharge, duration approx. 7-10 days) | No | |
Secondary | Extubation time | In-hospital period (until hospital discharge, duration approx. 7-10 days) | No | |
Secondary | Thromboembolic complications | In-hospital period (until hospital discharge, duration approx. 7-10 days) | No | |
Secondary | In-hospital infections | In-hospital period (until hospital discharge, duration approx. 7-10 days) | No | |
Secondary | In-hospital Mortality | In-hospital period (until hospital discharge, duration approx. 7-10 days) | No |
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