Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2025-12-26 @ 1:42 PM
Study NCT ID:
NCT05361759
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2022-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Tunisian Registry of Cardiac Implantable Electronic Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1518}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2022-04-30', 'studyFirstSubmitQcDate': '2022-04-30', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of patients undergoing cardiac implantable electronic devices in Tunisia', 'timeFrame': 'at inclusion', 'description': 'Number of subjects with heart disease (heart failure, rythm disorder) and willing to participate at the study and who are eligible for cardiac implantable electronic devices procedures'}], 'secondaryOutcomes': [{'measure': 'Heart complication', 'timeFrame': 'at 12 months of follow-up', 'description': 'Number of patients with cardiovascular event, including death, tamponade, pericarditis, heart failure, worsening of valvular disease, moving the right ventricular lead, compartment infection, phrenic stimulation, conductor breakage, or any other cardiovascular complication related to the cardiac implantable electronic device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Implantable Electronic Devices', 'Heart', 'Pacemaker', 'Implantable Cardioverter Defibrillator', 'Cardiac Loop Recorders', 'Biventricular Pacemakers', 'Heart rhythm disorder'], 'conditions': ['Cardiac Implantable Electronic Devices']}, 'referencesModule': {'references': [{'pmid': '38588529', 'type': 'DERIVED', 'citation': 'Chabrak S, Haggui A, Allouche E, Ouali S, Ben Halima A, Kacem S, Krichen S, Marrakchi S, Fehri W, Mourali MS, Jabbari Z, Ben Halima M, Neffati E, Heraiech A, Slim M, Kachboura S, Gamra H, Hassine M, Kraiem S, Kammoun S, Bezdah L, Jridi G, Bouraoui H, Kammoun S, Hammami R, Chettaoui R, Ben Ameur Y, Azaiez F, Tlili R, Battikh K, Ben Slima H, Chrigui R, Fazaa S, Sanaa I, Ellouz Y, Mosrati M, Milouchi S, Jarmouni S, Ayadi W, Akrout M, Razgallah R, Neffati W, Drissa M, Charfeddine S, Abdessalem S, Abid L, Zakhama L. National Tunisian Study of Cardiac Implantable Electronic Devices: Design and Protocol for a Nationwide Multicenter Prospective Observational Study. JMIR Res Protoc. 2024 Apr 8;13:e47525. doi: 10.2196/47525.'}], 'seeAlsoLinks': [{'url': 'http://www.stcccv-tunisie.com/', 'label': 'Tunisian Society of Cardiology and Cardiovascular Surgery Website'}]}, 'descriptionModule': {'briefSummary': 'The National Tunisian Registry of Cardiac Implantable Electronic Devices is an observational, prospective and multicenter study aiming to assess the epidemiological, clinical and therapeutic profile of cardiac implantable electronic Devices in Tunisia. Cardiologists from both sectors (public and private) are participating in the study, with 26 investigational centers. Data is captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \\& ICH (International Conference on Harmonisation) requirements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing cardiac implantable electronic device procedure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients originated from Tunisia\n* Signed informed consent\n* Patients undergoing a cardiac implantable electronic device procedure\n\nExclusion Criteria:\n\n* Informed Consent not given'}, 'identificationModule': {'nctId': 'NCT05361759', 'acronym': 'NATURE-CIED', 'briefTitle': 'National Tunisian Registry of Cardiac Implantable Electronic Devices', 'organization': {'class': 'OTHER', 'fullName': 'Dacima Consulting'}, 'officialTitle': 'National Tunisian Registry of Cardiac Implantable Electronic Devices (NATURE-CIED)', 'orgStudyIdInfo': {'id': 'DAC-012-NATURECIED'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cardiac Implantable Electronic Devices', 'type': 'DEVICE', 'description': 'Description of Cardiac Implantable Electronic Devices'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1053', 'city': 'Tunis', 'country': 'Tunisia', 'facility': 'The Tunisian Society of Cardiology and CardioVascular Surgery', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Sonia Chabrak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}, {'name': 'Abdeddayem Haggui, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}, {'name': 'Salma Krichène, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}, {'name': 'Slim Kacem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}, {'name': 'Sonia Marrakchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}, {'name': 'Emna Allouche, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tunisian Society of Cardiology and Cardiovascular Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dacima Consulting', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tunisian Society of Cardiology and Cardiovascular Surgery', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}