Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT01154205
Status:
UNKNOWN
Last Update Posted:
2010-06-30
First Post:
2010-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sheba Medical Center Home Monitoring Clinic Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-06-29', 'studyFirstSubmitDate': '2010-06-29', 'studyFirstSubmitQcDate': '2010-06-29', 'lastUpdatePostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-30', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clinical Workload Assessment Based Upon a Home Monitoring System']}, 'descriptionModule': {'briefSummary': 'The purpose of the registry is to assess workload of a Home Monitoring based follow up for Biotronik ICD and CRTD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients implanted with an ICD or CRTD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Approved indication for ICD or CRTD\n* Implanted with or replaced with a Biotronik Lumax device\n* Patient willing and able to sign consent form\n* Willing and able to attend clinic visits and follow up schedule\n* Transmission of more than 80% at 3-month follow up\n* Patient older than 18 years\n\nExclusion Criteria:\n\n* no indication for ICD or CRTD implant\n* Life expectancy shorter than 12 months\n* Pregnancy\n* Participation in other clinical studies'}, 'identificationModule': {'nctId': 'NCT01154205', 'briefTitle': 'Sheba Medical Center Home Monitoring Clinic Registry', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': 'Sheba Medical Center Home Monitoring Clinic Registry', 'orgStudyIdInfo': {'id': 'SHEBA-09-7598-DL-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients post implantation of ICD or CRTD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '52621', 'city': 'Tel Litwinsky', 'state': 'Ramat Gan', 'country': 'Israel', 'contacts': [{'name': 'David Luria, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michael Glikson, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Bar Lev, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Osnat Gurevitz, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}], 'centralContacts': [{'name': 'David Luria, MD', 'role': 'CONTACT', 'email': 'dluria@sheba.health.gov.il', 'phone': '972-52-6667111'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. David Luria', 'oldOrganization': 'Heart Center at Sheba Medical Center'}}}}