Elimination of Microemboli During Aortic Valve Replacement (ELMAR)

University of Giessen

Status: Unknown

Conditions: Neurocognitive Outcome After Aortic Valve Replacement

Treatments: Procedure: Embol-X intra-aortic emboli filter; Procedure: Control group; Procedure: DBT dynamic bubble trap

Study type: Interventional

Funder types: Other

Identifiers

NCT01128751

P41/09// A67/09

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Embol-X

Active Comparator group

Description:

Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.

Treatment:

Procedure: Embol-X intra-aortic emboli filter

DBT dynamic bubble trap

Active Comparator group

Description:

Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery

Treatment:

Procedure: DBT dynamic bubble trap

Control group

No Intervention group

Description:

In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery

Treatment:

Procedure: Control group