Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-13 @ 8:54 AM
Study NCT ID:
NCT03612635
Status:
COMPLETED
Last Update Posted:
2018-08-02
First Post:
2018-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications
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': 2811}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-27', 'studyFirstSubmitDate': '2018-07-19', 'studyFirstSubmitQcDate': '2018-07-27', 'lastUpdatePostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Death (dead/alive status assessment during follow-up)', 'timeFrame': 'An average of 48 months', 'description': 'Evaluation of all-cause mortality during follow-up'}], 'secondaryOutcomes': [{'measure': 'Occurrence of hospitalizations related to cardiac implantable electronic device complications', 'timeFrame': 'An average of 48 months', 'description': 'Evaluation of hospitalizations related to cardiac implantable electronic device complications'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Implantable Electronic Device Complications']}, 'referencesModule': {'references': [{'pmid': '38552177', 'type': 'DERIVED', 'citation': 'Palmisano P, Sergi C, Panico V, Chiarillo MV, Chiuri MD, Martella ML, Stefanelli G, Martella D, Mauro R, Ponzetta MA, Parlavecchio A, Accogli M, Coluccia G. Impact on nurse workload and patient satisfaction of atrioventricular junction ablation performed simultaneously with conduction system pacing using a superior approach from the pocket compared with the conventional femoral approach. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):746-755. doi: 10.1093/eurjcn/zvae043.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this registry is to evaluate the impact on patient outcome and on healthcare utilization of cardiac implantation electronic device complications during a long-term follow-up.', 'detailedDescription': 'Multicentric, observational, prospective registry enrolling consecutive patients underwent pacemaker or defibrillator implantation, aimed to evaluate the impact of cardiac implantable device complications requiring surgical revision on healthcare utilization (number and length of hospitalizations), and on patient outcome (all-cause mortality and cardiac mortality), during a long-term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with indication to receive a cardiac implantable electronic device (pacemaker or defibrillator).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients underwent cardiac implantable electronic device implantation according to current guidelines during the enrollment period.\n\nExclusion Criteria:\n\n* patients already carriers of a cardiac implantable electronic device underwent replacement or upgrading of device.'}, 'identificationModule': {'nctId': 'NCT03612635', 'acronym': 'POINTED', 'briefTitle': 'Impact on Patient Outcome of Cardiac Implantable Electronic Device Complications', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Cardinale G. Panico'}, 'officialTitle': 'Impact on Patient Outcome and Healthcare Utilization of Cardiac ImplaNTable Electronic Devices Complications', 'orgStudyIdInfo': {'id': 'POINTED'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Implantation of a cardiac implantable electronic device', 'type': 'DEVICE', 'description': 'All patients enrolled in the registry underwent cardiac implantable electronic device implantation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '73039', 'city': 'Tricase', 'state': 'Lecce', 'country': 'Italy', 'facility': '"Card. G. Panico" Hospital', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Federico Guerra', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Policlinico S.Orsola-Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Genova', 'country': 'Italy', 'facility': 'Mattia Laffi', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'Monaldi Hospital', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '28100', 'city': 'Novara', 'country': 'Italy', 'facility': 'AOU "Maggiore della Carità "', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Cardinale G. Panico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}