Elimination of Microemboli During Aortic Valve Replacement (ELMAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Giessen.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Else Kröner Fresenius Foundation
Information provided by:
University of Giessen
ClinicalTrials.gov Identifier:
NCT01128751
First received: May 18, 2010
Last updated: May 21, 2010
Last verified: May 2010
  Purpose

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.


Condition Intervention
Neurocognitive Outcome After Aortic Valve Replacement
Procedure: Embol-X intra-aortic emboli filter
Procedure: DBT dynamic bubble trap
Procedure: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial

Further study details as provided by University of Giessen:

Primary Outcome Measures:
  • Neuropsychological assessment 1 [ Time Frame: 3 weeks to 1 day before intervention ] [ Designated as safety issue: Yes ]
    Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures

  • Neuropsychological assessment 2 [ Time Frame: 3 months (+/- 1 week) post intervention ] [ Designated as safety issue: Yes ]
    Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures


Secondary Outcome Measures:
  • MRI lesions detected after surgery [ Time Frame: 2-6 days postoperative ] [ Designated as safety issue: Yes ]
    In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)


Estimated Enrollment: 150
Study Start Date: March 2010
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01128751

Contacts
Contact: Niko Schwarz, PhD +49(0)6032/999- ext 5811 niko.schwarz@neuro.med.uni-giessen.de
Contact: Tibo Gerriets, MD +40(0)6032/999- ext 5812 tibo.gerriets@neuro.med.uni-giessen.de

Locations
Germany
University Clinic Giessen Recruiting
35392 Giessen, Hessen, Germany, 35392
Sub-Investigator: Jörn Bohn         
Johann Wolfgang Goehte University Clinic Recruiting
60590 Frankfurt, Hessen, Germany, 60590
Sub-Investigator: Annika Löffler         
Kerckhoff Clinic Recruiting
61231 Bad Nauheim, Hessen, Germany, 61231
Principal Investigator: Niko Schwarz, PhD         
Sponsors and Collaborators
University of Giessen
Else Kröner Fresenius Foundation
  More Information

No publications provided

Responsible Party: PD Dr. Tibo Gerriets, Justus Liebig University, Department of Neurology
ClinicalTrials.gov Identifier: NCT01128751     History of Changes
Other Study ID Numbers: P41/09// A67/09
Study First Received: May 18, 2010
Last Updated: May 21, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Giessen:
Cognition
Neuroprotection
Cardiopulmonary bypass
Aortic valve replacement
Micro-emboli

ClinicalTrials.gov processed this record on August 28, 2014