Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-26 @ 1:21 AM
Study NCT ID:
NCT03604133
Status:
RECRUITING
Last Update Posted:
2021-01-22
First Post:
2018-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2028-08-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2018-07-18', 'studyFirstSubmitQcDate': '2018-07-18', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful Implantation', 'timeFrame': 'Two-week follow-up assessment', 'description': 'Patient undergoes surgery for ICD device implantation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arrhythmia']}, 'descriptionModule': {'briefSummary': 'The primary objectives for the registry is to evaluate the overall incidence of serious complications or adverse events for primary implants and replacement devices, and assess the cost and time efficiency for both physicians and patients. The Registry is a multi ASC data collection registry. Data collection will occur at the time of screening, implant, and 2 weeks after implant at the time of wound check.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals who require ICD to maintain optimal health.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician recommendation to receive the implant in an Ambulatory Surgical Center (ASC)\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT03604133', 'acronym': 'ASC ICD Reg', 'briefTitle': 'Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry', 'organization': {'class': 'OTHER', 'fullName': 'QuesGen Systems Inc'}, 'officialTitle': 'Ambulatory Surgical Center Implantable Cardioverter-Defibrillator Outcomes Registry', 'orgStudyIdInfo': {'id': '2018-310 Cardiac Registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving ICD devices'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84043', 'city': 'Lehi', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael Dutton', 'role': 'CONTACT', 'email': 'mdutton@cardiosp.com', 'phone': '801-358-4231'}], 'facility': 'Cardio Surgical Partners, LLC', 'geoPoint': {'lat': 40.39162, 'lon': -111.85077}}], 'centralContacts': [{'name': 'Michael Jarrett, MBA', 'role': 'CONTACT', 'email': 'mike.jarrett@quesgen.com', 'phone': '415-608-3570'}, {'name': 'Martin Jorgensen, PhD', 'role': 'CONTACT', 'email': 'martin.jorgensen@quesgen.com', 'phone': '650-777-7617'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'QuesGen Systems Inc', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardio Surgical Partners', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}