Elimination of Microemboli During Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Neurocognitive Outcome After Aortic Valve Replacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Embol-X

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

Group Type ACTIVE_COMPARATOR

Embol-X intra-aortic emboli filter

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

DBT dynamic bubble trap

Intervention Type PROCEDURE

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

Group Type NO_INTERVENTION

Control group

Intervention Type PROCEDURE

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

Interventions

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Embol-X intra-aortic emboli filter

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Control group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No