Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-21 @ 9:52 PM
Study NCT ID:
NCT02253134
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2013-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 395}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-30', 'studyFirstSubmitDate': '2013-07-10', 'studyFirstSubmitQcDate': '2014-09-30', 'lastUpdatePostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the mean value of the diagnostic yield in one month', 'timeFrame': '1 month', 'description': "number of pts with a conclusive diagnosis (per investigators' decision) over the total number of patients"}], 'secondaryOutcomes': [{'measure': 'Diagnostic yield of the ELR stratified by each kind of diagnosed event, by week and by event occurred post enrollment', 'timeFrame': '1 month'}, {'measure': 'Recurrence rate stratified by syncope /palpitation, by week and by type of events occurred post enrollment', 'timeFrame': '1 month'}, {'measure': 'Analysis of arrhythmic vs non arrhythmic findings stratified by kind of index events (syncope /palpitations)', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Syncopal events', 'Palpitation events'], 'conditions': ['Syncope', 'Palpitations']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the diagnostic yield (at 1 month post enrollment) of an external loop recorder (SpiderFlash-T) in patients with syncope or palpitations of suspected arrhythmic origin, within 30 days before enrollment.', 'detailedDescription': "Diagnostic yield (primary outcome) definition = Number of patients with conclusive diagnosis (as per investigators' decision) over the total number of patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients that present unexplained Syncope and/or palpitations events of a suspected arrhythmic origin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Syncope and/or palpitations events occurred in the last 30 days\n* Events likely of arrhythmic origin\n* No conclusive diagnosis established yet\n* High probability of episodes recurrence (presence of at least one previous event in the last 12 months)\n* Patient has signed the consent to participate to the study and/or to data treatment\n\nExclusion Criteria:\n\n* Inability to understand the purpose of the study or refusal to cooperate\n* Expected low compliance with the recording technique.\n* Logistical impossibility to deliver the ELR within 30 days after the index event (or after discharge from ER and/or hospitalization and/or clinic visit)\n* Already included in other competitor clinical study\n* Under guardianship\n* Age less than 18'}, 'identificationModule': {'nctId': 'NCT02253134', 'acronym': 'ITHO04', 'briefTitle': 'Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'LivaNova'}, 'officialTitle': 'Monitoring of Syncopes and/or Sustained Palpitations of Suspected Arrhythmic Origin With External Loop-Recorder (SpiderFLASH)', 'orgStudyIdInfo': {'id': 'SYNARR-FLASH STUDY - ITHO04'}}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Gasthuisberg Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '16033', 'city': 'Lavagna', 'country': 'Italy', 'facility': 'Az. Sanit. Locale N. 4 Chiavarese', 'geoPoint': {'lat': 44.3062, 'lon': 9.35383}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale Niguarda Ca Granda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Hospital de Santa Marta', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '08028', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Institut Universitari Dexeus', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '48013', 'city': 'Bilbao', 'country': 'Spain', 'facility': 'Hospital de Basurto', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Universitätsklinik für Kardiologie Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Emanuela T Locati', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Azienda Ospedaliera Niguarda Ca' Granda - Milano"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LivaNova', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}