Elimination of Microemboli During Aortic Valve Replacement

Not Applicable

• Conditions: Neurocognitive Outcome After Aortic Valve Replacement
• Interventions: Procedure: Embol-X intra-aortic emboli filter; Procedure: DBT dynamic bubble trap; Procedure: Control group

• Registration Number: NCT01128751
• Lead Sponsor: University of Giessen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Status Verified: 2010-05
• Study First Submitted: 2010-05-18
• Study First Submitted QC: 2010-05-21
• Last Update Submitted: 2010-05-21
• Study First Posted: 2010-05-24
• Last Update Posted: 2010-05-24
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Embol-X	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	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	Control group	In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery

Primary Outcome Measures

Name	Time	Method
Neuropsychological assessment 1	3 weeks to 1 day before intervention	Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures
Neuropsychological assessment 2	3 months (+/- 1 week) post intervention	Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures

Secondary Outcome Measures

Name	Time	Method
MRI lesions detected after surgery	2-6 days postoperative	In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)

Trial Locations

Locations (3)

University Clinic Giessen; 🇩🇪 35392 Giessen, Hessen, Germany

Johann Wolfgang Goehte University Clinic; 🇩🇪 60590 Frankfurt, Hessen, Germany

Kerckhoff Clinic; 🇩🇪 61231 Bad Nauheim, Hessen, Germany