Ignite Creation Date:
2025-12-26 @ 10:20 PM
Ignite Modification Date:
2026-04-14 @ 6:38 AM
Study NCT ID:
NCT02943512
Status:
UNKNOWN
Last Update Posted:
2017-05-03
First Post:
2016-10-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Same Day Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-01', 'studyFirstSubmitDate': '2016-10-21', 'studyFirstSubmitQcDate': '2016-10-21', 'lastUpdatePostDateStruct': {'date': '2017-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average number of late complications between the 2 arms', 'timeFrame': 'up to 2 weeks after procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiac Arrhythmia']}, 'descriptionModule': {'briefSummary': 'This study is to assess if subjects receiving a clinically indicated implanted cardiac pacemaker or defibrillator can be safely discharge home the same day of the procedure.', 'detailedDescription': 'Subjects who are implanted with a clinically indicated implanted cardiac pacemaker or defibrillator will be randomized to standard of care (next day discharge) versus same day discharge post implant. Both groups will under go standard of care assessments prior to discharge. The same day discharge group will receive a phone call the next day to assess for events and will transmit device data electronically. Both groups will be seen 10 - 14 days after implant for further evaluation.\n\nThe subjects will also complete questionnaires regarding their knowledge of self care and satisfaction with care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Scheduled for clinically indicated implant of cardiac pacemaker or defibrillator\n2. Willing and able to provide informed consent\n3. Appropriate clinical indication for the purpose of this study\n\n 1. Primary prevention implantable cardioverter-defibrillator implant indicated for sudden cardiac death with ejection fraction more than 20%\n 2. Sick sinus syndrome, non-high degree heart block as indication for pacemaker implant.\n 3. No history of syncope\n 4. No documented sudden cardiac death or ventricular arrhythmias requiring shock\n4. Adequate social support to be able to comply with protocol.\n5. Ability to complete remote monitor transmission\n\nExclusion Criteria:\n\n1\\. Determined to be at risk for bleeding or on oral anticoagulation 2. Planned to be implanted with non-Biotronik device 3. Complete heart block as indication for permanent pacemaker 4. Secondary ICD indication 5. Immediate procedural complication requiring prolonged admission such as: pneumothorax, large hematoma, tamponade) determined during the procedure or immediately before discharge.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02943512', 'briefTitle': 'Same Day Discharge', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Same Day Discharge', 'orgStudyIdInfo': {'id': '2016-3696'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Discharge day of Procedure', 'description': 'Subjects in this arm will be discharged the same day of their cardiac device implant if deemed safe by treating physician.', 'interventionNames': ['Other: Discharge day of procedure']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects in this arm will remain in the hospital overnight per standard of care and will be discharged the next day if deemed safe by treating physician.'}], 'interventions': [{'name': 'Discharge day of procedure', 'type': 'OTHER', 'description': 'Subjects will be discharged the day of the procedure if safe', 'armGroupLabels': ['Discharge day of Procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alexandru Costea, MD', 'role': 'CONTACT', 'email': 'costeaai@ucmail.uc.edu', 'phone': '513-558-4272'}, {'name': 'Ginger Conway, MSN', 'role': 'CONTACT', 'email': 'conwaygg@ucmail.uc.edu', 'phone': '513-558-3476'}], 'facility': 'University of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'centralContacts': [{'name': 'Alexandru Costea, MD', 'role': 'CONTACT', 'email': 'costeaai@ucmail.uc.edu', 'phone': '513-558-4272'}, {'name': 'Ginger Conway, MSN', 'role': 'CONTACT', 'email': 'conwaygg@ucmail.uc.edu', 'phone': '513-558-3476'}], 'overallOfficials': [{'name': 'Alexandru Costea, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Cincinnati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexandru Costea', 'investigatorAffiliation': 'University of Cincinnati'}}}}