Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-25 @ 3:12 PM
Study NCT ID:
NCT06656468
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-10-24
First Post:
2024-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Patients Undergoing Leadless Pacemaker Implantaton
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001919', 'term': 'Bradycardia'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D047548', 'term': 'Defibrillators'}], 'ancestors': [{'id': 'D004566', 'term': 'Electrodes'}, {'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-10-21', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute complications', 'timeFrame': 'From date of implantation until the date of first documented complication, assessed up to 30 days.', 'description': 'Acute complications related to leadless pacemaker implantation'}], 'secondaryOutcomes': [{'measure': 'Long-term complications', 'timeFrame': 'From 31th day from implantation until the date of first documented complication, assessed up to 6 months.', 'description': 'Complications related to leadless pacemaker implantation observed during long-term follow-up'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bradyarrhythmias', 'leadless pacemaker', 'complications'], 'conditions': ['Bradyarrhythmias']}, 'referencesModule': {'references': [{'pmid': '36036679', 'type': 'BACKGROUND', 'citation': 'Palmisano P, Facchin D, Ziacchi M, Nigro G, Nicosia A, Bongiorni MG, Tomasi L, Rossi A, De Filippo P, Sgarito G, Verlato R, Di Silvestro M, Iacopino S. Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an Italian multicentre large population analysis. Europace. 2023 Feb 8;25(1):112-120. doi: 10.1093/europace/euac112.'}]}, 'descriptionModule': {'briefSummary': 'Observational study aimed to evaluate the rate and of complications related to lealdless pacemaker implantation.', 'detailedDescription': 'Observational, multicenter study enrolling consecutive patients undergoing leadless pacemaker implantation. Procedure details, intraprocedural complications, and n-hospital outcomes will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with indication for leadless pacemaker implantation for symptomatic bradyarrhythmias according to current Guidelines on cardiac pacing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with indication for leadless pacemaker implantation according to current Guidelines on cardiac pacing.\n\nExclusion Criteria:\n\n* inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT06656468', 'acronym': 'OPUPI', 'briefTitle': 'Outcome of Patients Undergoing Leadless Pacemaker Implantaton', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliera Cardinale G. Panico'}, 'officialTitle': 'Outcome of Patients Undergoing Leadless Pacemaker Implantaton', 'orgStudyIdInfo': {'id': 'OPUPI registry'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Leadless pacemaker patients', 'description': 'Consecutive patients undergoing leadless pacemaker patients', 'interventionNames': ['Device: Pacemaker and defibrillator']}], 'interventions': [{'name': 'Pacemaker and defibrillator', 'type': 'DEVICE', 'description': 'Leadless pacemaker implantation procedure performed accordng to usual clinical practice. The indication for pacemaker implantation will be based on current guidelines.', 'armGroupLabels': ['Leadless pacemaker patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73039', 'city': 'Tricase', 'country': 'Italy', 'facility': 'Azienda Ospedaliera "Card. G. Panico"', 'geoPoint': {'lat': 39.93018, 'lon': 18.35421}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliera Cardinale G. Panico', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pietro Palmisano', 'investigatorAffiliation': 'Azienda Ospedaliera Cardinale G. Panico'}}}}