Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-03-03 @ 2:19 AM
Study NCT ID:
NCT03508128
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2018-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of EMI in Patients With Micra Leadless Pacemaker
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-19', 'studyFirstSubmitDate': '2018-04-05', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EMI', 'timeFrame': 'up to 6 months next postop interrogation', 'description': 'Number of subjects with evidence of EMI determined by sensing integrity counter and heart rate histograms'}], 'secondaryOutcomes': [{'measure': 'Device reset', 'timeFrame': 'up to 6 months next postop interrogation', 'description': 'Number of subjects with change in programmed parameters showing device reset VVI 65 5V@.4ms'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Electromagnetic Interference']}, 'descriptionModule': {'briefSummary': 'Subjects with Medtronic Micra leadless pacemaker who require surgical procedures will have postoperative interrogations reviewed for evidence of electromagnetic interference (EMI).', 'detailedDescription': 'Patients with pacemakers have a potential risk of EMI from sources including electrosurgery which can cause oversensing, pacing inhibition and device reset. There is limited data on surgical EMI in Medtronic Micra leadless pacemakers. The goal of this study is to evaluate for surgical EMI in subjects with leadless pacemakers.\n\nSubjects with Micra leadless pacemakers requiring surgery will have procedure records reviewed for type of procedure and use of electrosurgery. Next postoperative device interrogation will be reviewed for evidence of EMI. EMI will be evaluated by review of sensing integrity counter, heart rate histograms and device reset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with Micra leadless pacemakers implanted at Edward-Elmhurst Healthcare since May 2016 who then required a surgical procedure.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* subjects with an implanted Micra pacemaker who required a surgical procedure\n\nExclusion Criteria:\n\n* no Micra pacemaker'}, 'identificationModule': {'nctId': 'NCT03508128', 'briefTitle': 'Evaluation of EMI in Patients With Micra Leadless Pacemaker', 'organization': {'class': 'OTHER', 'fullName': 'Edward-Elmhurst Health System'}, 'officialTitle': 'Evaluation of Surgical Electromagnetic Interference in Medtronic Micra Leadless Pacemaker', 'orgStudyIdInfo': {'id': 'EdwardH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Micra subjects', 'description': 'Surgical procedure', 'interventionNames': ['Other: surgical procedure']}], 'interventions': [{'name': 'surgical procedure', 'type': 'OTHER', 'description': 'Surgical procedure', 'armGroupLabels': ['Micra subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60174', 'city': 'Naperville', 'state': 'Illinois', 'country': 'United States', 'facility': 'EdwardElmhurst Healthcare', 'geoPoint': {'lat': 41.78586, 'lon': -88.14729}}], 'overallOfficials': [{'name': 'Janet Gifford, MSN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Edward-Elmhurst Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Edward-Elmhurst Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nurse Practitioner', 'investigatorFullName': 'Janet Gifford', 'investigatorAffiliation': 'Edward-Elmhurst Health System'}}}}