Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT01128751
Status:
UNKNOWN
Last Update Posted:
2010-05-24
First Post:
2010-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elimination of Microemboli During Aortic Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'lastUpdateSubmitDate': '2010-05-21', 'studyFirstSubmitDate': '2010-05-18', 'studyFirstSubmitQcDate': '2010-05-21', 'lastUpdatePostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological assessment 1', 'timeFrame': '3 weeks to 1 day before intervention', 'description': 'Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures'}, {'measure': 'Neuropsychological assessment 2', 'timeFrame': '3 months (+/- 1 week) post intervention', 'description': 'Patients are assessed by an extensive neuropsychological test battery to test cognitive functions and psychological measures'}], 'secondaryOutcomes': [{'measure': 'MRI lesions detected after surgery', 'timeFrame': '2-6 days postoperative', 'description': 'In MRI micro-embolic lesions are detected using diffusion weighted imaging (DWI)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cognition', 'Neuroprotection', 'Cardiopulmonary bypass', 'Aortic valve replacement', 'Micro-emboli'], 'conditions': ['Neurocognitive Outcome After Aortic Valve Replacement']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Elective aortic valve replacement\n* Informed consent\n* German language\n\nExclusion Criteria:\n\n* 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\n* Contraindication against MRI assessment'}, 'identificationModule': {'nctId': 'NCT01128751', 'acronym': 'ELMAR', 'briefTitle': 'Elimination of Microemboli During Aortic Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'University of Giessen'}, 'officialTitle': 'ELMAR - Elimination of Microemboli During Aortic Valve Replacement. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'P41/09// A67/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Embol-X', 'description': 'Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.', 'interventionNames': ['Procedure: Embol-X intra-aortic emboli filter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'DBT dynamic bubble trap', 'description': 'Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery', 'interventionNames': ['Procedure: DBT dynamic bubble trap']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery', 'interventionNames': ['Procedure: Control group']}], 'interventions': [{'name': 'Embol-X intra-aortic emboli filter', 'type': 'PROCEDURE', 'description': 'Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.', 'armGroupLabels': ['Embol-X']}, {'name': 'DBT dynamic bubble trap', 'type': 'PROCEDURE', 'description': 'Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery', 'armGroupLabels': ['DBT dynamic bubble trap']}, {'name': 'Control group', 'type': 'PROCEDURE', 'description': 'In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35392', 'city': '35392 Giessen', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörn Bohn', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Clinic Giessen'}, {'zip': '60590', 'city': '60590 Frankfurt', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Annika Löffler', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Johann Wolfgang Goehte University Clinic'}, {'zip': '61231', 'city': '61231 Bad Nauheim', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Niko Schwarz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kerckhoff Clinic'}], 'centralContacts': [{'name': 'Niko Schwarz, PhD', 'role': 'CONTACT', 'email': 'niko.schwarz@neuro.med.uni-giessen.de', 'phone': '+49(0)6032/999-', 'phoneExt': '5811'}, {'name': 'Tibo Gerriets, MD', 'role': 'CONTACT', 'email': 'tibo.gerriets@neuro.med.uni-giessen.de', 'phone': '+40(0)6032/999-', 'phoneExt': '5812'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Giessen', 'class': 'OTHER'}, 'collaborators': [{'name': 'Else Kröner Fresenius Foundation', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'PD Dr. Tibo Gerriets', 'oldOrganization': 'Justus Liebig University, Department of Neurology'}}}}