Elimination of Microemboli During Aortic Valve Replacement

Neurocognitive Outcome After Aortic Valve Replacement Clinical Trial

— ELMAR  

Official title:

ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01128751
• Other study ID #: P41/09// A67/09
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2010
• Last updated: May 21, 2010
• Start date: March 2010

Study information

• Verified date: May 2010
• Source: University of Giessen
• Contact: Niko Schwarz, PhD
• Phone: +49(0)6032/999-
• Email: niko.schwarz[@]neuro.med.uni-giessen.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Neurocognitive Outcome After Aortic Valve Replacement

Intervention

Procedure:
• Embol-X intra-aortic emboli filter
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
• DBT dynamic bubble trap
Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
• Control group
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery

Locations

Country	Name	City	State
Germany	University Clinic Giessen	35392 Giessen	Hessen
Germany	Johann Wolfgang Goehte University Clinic	60590 Frankfurt	Hessen
Germany	Kerckhoff Clinic	61231 Bad Nauheim	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
University of Giessen	Else Kröner Fresenius Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological assessment 1	Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures	3 weeks to 1 day before intervention	Yes
Primary	Neuropsychological assessment 2	Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures	3 months (+/- 1 week) post intervention	Yes
Secondary	MRI lesions detected after surgery	In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)	2-6 days postoperative	Yes