Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT00701467
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2008-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-17', 'studyFirstSubmitDate': '2008-06-18', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in RR interval recorded by ICD', 'timeFrame': 'within an hour before ventricular tachyarrythmia'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICD', 'ICD implanted patients'], 'conditions': ['Ventricular Tachyarrhythmia']}, 'descriptionModule': {'briefSummary': 'To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ICD clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* S/P lexos VR/-T,DR/-T implantation\n* Signed patient informed consent\n\nExclusion Criteria:\n\n* CAF\n* Life expectancy\\<6 months\n* Impending heart transplant\n* Persistent recurring tachycardia\n* Rhythm disturbances that preclude a meaningful HRV analysis\n* Participation in another study.'}, 'identificationModule': {'nctId': 'NCT00701467', 'acronym': 'HRV', 'briefTitle': 'Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia', 'orgStudyIdInfo': {'id': 'SHEBA-4743-07-MG-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Arrythmia Service Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}], 'overallOfficials': [{'name': 'Michael Glikson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SHEBA MC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director , Davidai Arrhythmia Center, Leviev Heart Center', 'investigatorFullName': 'Prof. Michael Glikson', 'investigatorAffiliation': 'Sheba Medical Center'}}}}