NCT01128751

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 24, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

May 24, 2010

Status Verified

May 1, 2010

Enrollment Period

1.8 years

First QC Date

May 18, 2010

Last Update Submit

May 21, 2010

Conditions

Neurocognitive Outcome After Aortic Valve Replacement

Keywords

CognitionNeuroprotectionCardiopulmonary bypassAortic valve replacementMicro-emboli

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • MRI lesions detected after surgery

    2-6 days postoperative

Study Arms (3)

Embol-X

ACTIVE COMPARATOR

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

Procedure: Embol-X intra-aortic emboli filter

DBT dynamic bubble trap

ACTIVE COMPARATOR

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

Procedure: DBT dynamic bubble trap

Control group

NO INTERVENTION

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

Procedure: Control group

Interventions

Embol-X intra-aortic emboli filterPROCEDURE

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

Embol-X
DBT dynamic bubble trapPROCEDURE

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

DBT dynamic bubble trap
Control groupPROCEDURE

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Elective aortic valve replacement
  • Informed consent
  • German language

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University Clinic Giessen

35392 Giessen, Hesse, 35392, Germany

RECRUITING

Johann Wolfgang Goehte University Clinic

60590 Frankfurt, Hesse, 60590, Germany

RECRUITING

Kerckhoff Clinic

61231 Bad Nauheim, Hesse, 61231, Germany

RECRUITING

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Niko Schwarz, PhD

CONTACT

+49(0)6032/999-niko.schwarz@neuro.med.uni-giessen.de

Tibo Gerriets, MD

CONTACT

+40(0)6032/999-tibo.gerriets@neuro.med.uni-giessen.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 24, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2011

Last Updated

May 24, 2010

Record last verified: 2010-05

Locations

DE(3)