Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2026-01-09 @ 4:54 AM
Study NCT ID:
NCT02700633
Status:
UNKNOWN
Last Update Posted:
2016-03-07
First Post:
2016-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2016-03-02', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 day mortality', 'timeFrame': '30 dyas'}], 'secondaryOutcomes': [{'measure': '60 day mortality', 'timeFrame': '60 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['TAVI']}, 'descriptionModule': {'briefSummary': 'Pacemaker requirement in the immediate post procedure phase following TAVI is approximately 20% depending on device type and patient characteristics. There is a signal from recent studies suggesting increased risk of sudden cardiac / unexplained death in the first 30-60 days. This study aims to address whether there is a mortality advantage to having a pacemaker in the short term'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients post TAVI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients post TAVI\n\nExclusion Criteria:\n\n* Nil'}, 'identificationModule': {'nctId': 'NCT02700633', 'briefTitle': 'Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI', 'organization': {'class': 'OTHER', 'fullName': 'Royal Sussex County Hospital'}, 'officialTitle': 'Does Permanent Pacemaker Status Confer Mortality Benefit in the Short Term Post TAVI', 'orgStudyIdInfo': {'id': 'TAVIPPMEarlyMortality'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Those with pacemaker at discharge', 'description': 'Landmark analysis of early mortality dependant on pacemaker status at discharge', 'interventionNames': ['Device: Pacemaker']}, {'label': 'Those without pacemaker at discharge', 'description': 'Landmark analysis of early mortality dependant on pacemaker status at discharge'}], 'interventions': [{'name': 'Pacemaker', 'type': 'DEVICE', 'armGroupLabels': ['Those with pacemaker at discharge']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Sussex County Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Cardiologist', 'investigatorFullName': 'David Hildick-Smith', 'investigatorAffiliation': 'Royal Sussex County Hospital'}}}}