Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT01009320
Status:
COMPLETED
Last Update Posted:
2013-03-06
First Post:
2009-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-05', 'studyFirstSubmitDate': '2009-11-05', 'studyFirstSubmitQcDate': '2009-11-05', 'lastUpdatePostDateStruct': {'date': '2013-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Asynchronous pacing', 'timeFrame': 'Minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pacemaker', 'Magnets', 'Drape', 'Ferrite', 'Magnetic field', 'Pacemaker interference'], 'conditions': ['Cardiac Pacemaker, Artificial']}, 'descriptionModule': {'briefSummary': 'Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to hold surgical instruments is widely used in surgery. The use of this drape on pacemaker patients has not yet been tested. Our objective is to conduct a clinical study to evaluate the potential interference of the surgical magnetic drape on patients with cardiac pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The totality of the drape is applied over the pacemaker and depending on the result, the drape is either folded in two over the pacemaker or the magnets are applied individually up to the totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm caudally until the interference is ceased. Results are in process as we are presently actively recruiting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Out-patient clinic', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cardiac pacemaker\n\nExclusion Criteria:\n\n* Unstable angina\n* Hemodynamic instability\n* Subjects whom the cardiologist believes are unsuitable for asynchronous pacing'}, 'identificationModule': {'nctId': 'NCT01009320', 'briefTitle': 'The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers', 'organization': {'class': 'OTHER', 'fullName': 'Maisonneuve-Rosemont Hospital'}, 'officialTitle': 'The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers', 'orgStudyIdInfo': {'id': 'HMRvzaphi'}, 'secondaryIdInfos': [{'id': '09051'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pacemaker with magnets', 'description': 'Patients with pacemakers who will be tested for magnetic interference with a magnetic drape.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Maisonneuve-Rosemont hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Louis-Philippe Fortier, MD, FRCPC', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maisonneuve-Rosemont hospital, University of Montreal'}, {'name': 'Valerie Zaphiratos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maisonneuve-Rosemont hospital, University of Montreal'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maisonneuve-Rosemont Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Valerie Zaphiratos', 'investigatorAffiliation': 'Maisonneuve-Rosemont Hospital'}}}}