Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-29 @ 4:45 PM
Study NCT ID:
NCT04926792
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-20
First Post:
2021-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taiwan Registry for Leadless Pacemaker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012804', 'term': 'Sick Sinus Syndrome'}, {'id': 'D054537', 'term': 'Atrioventricular Block'}], 'ancestors': [{'id': 'D001146', 'term': 'Arrhythmia, Sinus'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006327', 'term': 'Heart Block'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-17', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute complication', 'timeFrame': 'On the 1 day of implant procedure', 'description': 'Any acute complication during procedure'}, {'measure': 'Subacute complication', 'timeFrame': 'within 3 month after implant procedure', 'description': 'Any subacute complication, including pacemaker syndrome'}, {'measure': 'Leadless Pacemaker performance', 'timeFrame': 'aroung 12 months after implant proceure', 'description': 'The AV synchrony or pacemaker parameters'}], 'secondaryOutcomes': [{'measure': 'Successful implant', 'timeFrame': '1 day', 'description': 'The attempts of deployment in one procedure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Leadless Pacemaker', 'Taiwan'], 'conditions': ['Sick Sinus Syndrome', 'Atrioventricular Block']}, 'descriptionModule': {'briefSummary': 'Taiwan Registry for Leadless Pacemaker is a nationwide registry for leadless pacemaker performance in Taiwan.', 'detailedDescription': 'The purpose of this registry is to investigate the safety and efficiency performance of the leadless pacemakers in Taiwan. The registry will collect all the information about the patient selection, implantation procedure, and follow up parameters of the leadless pacemakers to evaluate the real-world benefit specifically in Taiwan population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'who attempt or had successfully received a leadless pacemaker implantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The patients who had successfully received leadless pacemaker implantation\n2. The patients who attempt to receive leadless pacemaker implantation\n\nExclusion Criteria:\n\nN/A'}, 'identificationModule': {'nctId': 'NCT04926792', 'briefTitle': 'Taiwan Registry for Leadless Pacemaker', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Taiwan Registry for Leadless Pacemaker', 'orgStudyIdInfo': {'id': '202103105RINB'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Leadless Pacemaker', 'type': 'DEVICE', 'description': 'Leadless pacemaker implantation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Chih-Chieh Yu, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taiwan Society of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taiwan Society of Cardiology', 'class': 'UNKNOWN'}, {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}