Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-23 @ 3:30 PM
Study NCT ID:
NCT02016950
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2013-12-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Pacemaker Arrhythmia Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2551}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-10', 'studyFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Atrial fibrillation burden', 'timeFrame': '28 days to 1 year', 'description': 'Proportion of monitored time in atrial fibrillation'}], 'secondaryOutcomes': [{'measure': 'Atrial fibrillation episode frequency', 'timeFrame': '28 days to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '26023175', 'type': 'DERIVED', 'citation': 'Sugihara C, Veasey R, Freemantle N, Podd S, Furniss S, Sulke N. The development of AF over time in patients with permanent pacemakers: objective assessment with pacemaker diagnostics demonstrates distinct patterns of AF. Europace. 2015 Jun;17(6):864-70. doi: 10.1093/europace/euv032.'}]}, 'descriptionModule': {'briefSummary': 'Investigators seek to observe the long term patterns of arrhythmias detected by permanent pacemakers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Those with permanent pacemakers', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pre-existing dual chamber permanent pacemaker\n\nExclusion Criteria:\n\n* Nil'}, 'identificationModule': {'nctId': 'NCT02016950', 'briefTitle': 'Long-term Pacemaker Arrhythmia Analysis', 'organization': {'class': 'OTHER', 'fullName': 'Eastbourne General Hospital'}, 'officialTitle': 'East Sussex Long-term Pacemaker Arrhythmia Analysis', 'orgStudyIdInfo': {'id': 'ESHT Pacemaker analysis'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Permanent pacemaker', 'description': 'Pre-existing permanent pacemakers'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BN21 2UD', 'city': 'Eastbourne', 'state': 'E Sussex', 'country': 'United Kingdom', 'facility': 'Eastbourne General Hospital', 'geoPoint': {'lat': 50.76871, 'lon': 0.28453}}], 'overallOfficials': [{'name': 'Neil Sulke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastbourne General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastbourne General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'Neil Sulke', 'investigatorAffiliation': 'Eastbourne General Hospital'}}}}