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Elimination of Microemboli During Aortic Valve Replacement

NCT01128751 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-05-24

No results posted yet for this study

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.

Conditions

  • Neurocognitive Outcome After Aortic Valve Replacement

Interventions

PROCEDURE

Embol-X intra-aortic emboli filter

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

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

PROCEDURE

Control group

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

Sponsors & Collaborators

  • Else Kröner Fresenius Foundation

    collaborator OTHER

  • University of Giessen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-12-31

Countries

  • Germany

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01128751 on ClinicalTrials.gov