Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT03530904
Status:
UNKNOWN
Last Update Posted:
2018-05-21
First Post:
2018-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Early and Late Mobilization After Cardiac Device Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-08', 'studyFirstSubmitDate': '2018-04-02', 'studyFirstSubmitQcDate': '2018-05-08', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lead dislodgement', 'timeFrame': 'one month', 'description': 'incidence of device lead dislodgement'}], 'secondaryOutcomes': [{'measure': "Patients' comfort level", 'timeFrame': 'one month', 'description': 'comfort level based on immobilization comfort questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pacemaker, Artificial']}, 'descriptionModule': {'briefSummary': 'Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.', 'detailedDescription': "Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients.\n\nPatients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure.\n\nPrimary outcome: lead malfunction, patients' satisfaction"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nAll patients undergoing device implantation and are hemodynamically stable\n\nExclusion Criteria:\n\n* hemodincamically unstable\n* patient's request"}, 'identificationModule': {'nctId': 'NCT03530904', 'briefTitle': 'Comparison Between Early and Late Mobilization After Cardiac Device Implantation', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator', 'orgStudyIdInfo': {'id': 'CMC-17-0015-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'early mobilization after cardiac device implantation', 'description': 'mobilization after 4 hours', 'interventionNames': ['Other: mobilization']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late mobilization after cardiac device implantation', 'description': 'Mobilization after 24 hours', 'interventionNames': ['Other: mobilization']}], 'interventions': [{'name': 'mobilization', 'type': 'OTHER', 'description': 'Early mobilization after CIED implantation', 'armGroupLabels': ['Late mobilization after cardiac device implantation', 'early mobilization after cardiac device implantation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Asaf Danon', 'investigatorAffiliation': 'Carmel Medical Center'}}}}