Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-24 @ 12:00 PM
Study NCT ID:
NCT00170261
Status:
COMPLETED
Last Update Posted:
2025-07-03
First Post:
2005-09-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013575', 'term': 'Syncope'}], 'ancestors': [{'id': 'D014474', 'term': 'Unconsciousness'}, {'id': 'D003244', 'term': 'Consciousness Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2006-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost of diagnostics per patient until final cardiac diagnosis has been made'}], 'secondaryOutcomes': [{'measure': 'Cost of diagnostics until final diagnosis has been made'}, {'measure': 'Rate of correct cardiac diagnoses'}, {'measure': 'Comparison of time needed to make a diagnosis'}, {'measure': 'Comparison of pre-syncopes and syncopes occuring in both groups after enrollment'}]}, 'conditionsModule': {'keywords': ['Syncope of uncertain etiology', 'Repeated presyncopes'], 'conditions': ['Syncope']}, 'descriptionModule': {'briefSummary': 'This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes\n\nExclusion Criteria:\n\n* Indication for the implantation of a pacemaker\n* Indication for the implantation of an implantable cardioverter defibrillator\n* Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular \\[LV\\] outflow stenosis, decompensated heart failure)\n* Contraindication for a diagnostic procedure requested by the study protocol\n* Enrollment in another study\n* Circumstances or comorbidities which do not allow enrollment'}, 'identificationModule': {'nctId': 'NCT00170261', 'briefTitle': 'ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Cardiac Rhythm and Heart Failure'}, 'officialTitle': 'Early Loop-Recorder in Suspected Arrhythmogenic Syncope', 'orgStudyIdInfo': {'id': 'CEN_G_CA_4'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Use of an Implantable Loop Recorder', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10967', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Vivantes Klinikum am Urban', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13509', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Humbold Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20251', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitätsklinikum Hamburg Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'H.-C- Ehlers, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vivantes Klinikum am Urban'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Cardiac Rhythm and Heart Failure', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}]}}}