Elimination of Microemboli During Aortic Valve Replacement (ELMAR)

May 21, 2010 updated by: University of Giessen

ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • 35392 Giessen, Hessen, Germany, 35392
        • Recruiting
        • University clinic Giessen
        • Sub-Investigator:
          • Jörn Bohn
      • 60590 Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Johann Wolfgang Goehte University Clinic
        • Sub-Investigator:
          • Annika Löffler
      • 61231 Bad Nauheim, Hessen, Germany, 61231
        • Recruiting
        • Kerckhoff Clinic
        • Principal Investigator:
          • Niko Schwarz, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Embol-X
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
Procedure: Embol-X intra-aortic emboli filter
Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
Active Comparator: 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: 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
No Intervention: Control group
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery
Procedure: Control group
In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI lesions detected after surgery
Time Frame: 2-6 days postoperative
In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)
2-6 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Giessen

Collaborators

Else Kröner Fresenius Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2011

Study Registration Dates

First Submitted

May 18, 2010

First Submitted That Met QC Criteria

May 21, 2010

First Posted (Estimate)

May 24, 2010

Study Record Updates

Last Update Posted (Estimate)

May 24, 2010

Last Update Submitted That Met QC Criteria

May 21, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • P41/09// A67/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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