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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02308566
Other study ID # 034/11
Secondary ID
Status Completed
Phase Phase 4
First received December 2, 2014
Last updated June 29, 2016
Start date June 2011
Est. completion date June 2016

Study information

Verified date June 2016
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Minimized Extracorporeal Circulation (MECC)
This group of patients receives surgical aortic valve replacement using MECC.
Conventional Extracorporeal Circulation (CECC)
This group of patients receives surgical aortic valve replacement using CECC.

Locations

Country Name City State
Switzerland University Hospital Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

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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