Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2026-02-08 @ 5:10 PM
Study NCT ID:
NCT07155135
Status:
COMPLETED
Last Update Posted:
2025-09-04
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices
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': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Changes in Device Battery Voltage (Volts)', 'timeFrame': 'Immediately Prior to MRI and Immediately after MRI', 'description': 'report Device Battery Voltage (in Volts) prior to the MRI and after the MRI and determine if there was a change in voltage greater than 10% from the initial measurement to the final measurement.'}, {'measure': 'Evaluation of Changes in Lead Impedance (Ohms)', 'timeFrame': 'Immediately Prior to MRI and Immediately after MRI', 'description': 'report lead impedance (in Ohms) prior to the MRI and after the MRI and determine if there is a change in impedence greater than 20% from the initial measurement to the final measurement.'}, {'measure': 'Evaluation of Changes in Lead Threshold (Voltage) Before and After MRI', 'timeFrame': 'Immediately Prior to MRI and Immediately after MRI', 'description': 'report lead threshold in (voltage) prior to MRI and after the MRI and determine if there is a change greater than10% from the initial measurement to the final measurement.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI', 'timeFrame': 'Immediately Prior to MRI and Immediately after MRI', 'description': 'We will review medical records and determine if there were any observed change in patient rhythm, symptoms (such as chest pain, syncope), cardiac arrest or death after the MRI was completed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac implantable electronic devices', 'CIED', 'MRI', 'Magnetic Resonance Imaging', 'safety'], 'conditions': ['Safety of MRI']}, 'referencesModule': {'references': [{'pmid': '28225684', 'type': 'RESULT', 'citation': 'Russo RJ, Costa HS, Silva PD, Anderson JL, Arshad A, Biederman RW, Boyle NG, Frabizzio JV, Birgersdotter-Green U, Higgins SL, Lampert R, Machado CE, Martin ET, Rivard AL, Rubenstein JC, Schaerf RH, Schwartz JD, Shah DJ, Tomassoni GF, Tominaga GT, Tonkin AE, Uretsky S, Wolff SD. Assessing the Risks Associated with MRI in Patients with a Pacemaker or Defibrillator. N Engl J Med. 2017 Feb 23;376(8):755-764. doi: 10.1056/NEJMoa1603265.'}, {'type': 'RESULT', 'citation': 'Nazarian, S., Hansford, R., Rahsepar, A. A., et al. (2021). "MRI for patients with non-MRI-conditional cardiac devices." The New England Journal of Medicine, 384(7), 674-675.'}, {'type': 'RESULT', 'citation': 'Russo, R. J., Costa, H. S., Silva, P. D., et al. (2017). "Assessing the risks associated with MRI in patients with cardiac devices." Journal of the American College of Cardiology, 69(8), 1123-1133.'}, {'pmid': '39452284', 'type': 'RESULT', 'citation': 'Lanz H, Strauss K, Hopler J, Kraft M, Hoffmann S, Binzenhofer L, Gade N, Roden D, Saleh I, Kaab S, Lackermair K, Sadoni S, Hagl C, Massberg S, Estner H, Fichtner S, Lusebrink E. Safety of Magnetic Resonance Imaging in Patients with Cardiac Implantable Electronic Devices. J Cardiovasc Dev Dis. 2024 Oct 8;11(10):313. doi: 10.3390/jcdd11100313.'}, {'pmid': '29281579', 'type': 'RESULT', 'citation': 'Nazarian S, Hansford R, Rahsepar AA, Weltin V, McVeigh D, Gucuk Ipek E, Kwan A, Berger RD, Calkins H, Lardo AC, Kraut MA, Kamel IR, Zimmerman SL, Halperin HR. Safety of Magnetic Resonance Imaging in Patients with Cardiac Devices. N Engl J Med. 2017 Dec 28;377(26):2555-2564. doi: 10.1056/NEJMoa1604267.'}, {'pmid': '28960745', 'type': 'RESULT', 'citation': 'Mason S, Osborn JS, Dhar R, Tonkin A, Ethington JD, Le V, Benuzillo J, Lappe DL, Knowlton KU, Bunch TJ, Anderson JL. Real world MRI experience with nonconditional and conditional cardiac rhythm devices after MagnaSafe. J Cardiovasc Electrophysiol. 2017 Dec;28(12):1468-1474. doi: 10.1111/jce.13351. Epub 2017 Nov 1.'}, {'pmid': '17362687', 'type': 'RESULT', 'citation': 'Martin ET, Sandler DA. MRI in patients with cardiac devices. Curr Cardiol Rep. 2007 Mar;9(1):63-71. doi: 10.1007/s11886-007-0012-y.'}, {'pmid': '10561087', 'type': 'RESULT', 'citation': 'Madigan JD, Choudhri AF, Chen J, Spotnitz HM, Oz MC, Edwards N. Surgical management of the patient with an implanted cardiac device: implications of electromagnetic interference. Ann Surg. 1999 Nov;230(5):639-47. doi: 10.1097/00000658-199911000-00005.'}, {'pmid': '781163', 'type': 'RESULT', 'citation': 'Driller J, Barold SS, Parsonnet V. Normal and abnormal function of the pacemaker magnetic reed switch. J Electrocardiol. 1976;9(3):283-92. doi: 10.1016/s0022-0736(76)80058-1.'}, {'pmid': '15944094', 'type': 'RESULT', 'citation': 'Irnich W, Irnich B, Bartsch C, Stertmann WA, Gufler H, Weiler G. Do we need pacemakers resistant to magnetic resonance imaging? Europace. 2005 Jul;7(4):353-65. doi: 10.1016/j.eupc.2005.02.120.'}, {'pmid': '15618060', 'type': 'RESULT', 'citation': 'Luechinger R, Zeijlemaker VA, Pedersen EM, Mortensen P, Falk E, Duru F, Candinas R, Boesiger P. In vivo heating of pacemaker leads during magnetic resonance imaging. Eur Heart J. 2005 Feb;26(4):376-83; discussion 325-7. doi: 10.1093/eurheartj/ehi009. Epub 2004 Nov 29.'}, {'pmid': '24066196', 'type': 'RESULT', 'citation': 'Kodali S, Baher A, Shah D. Safety of MRIs in patients with pacemakers and defibrillators. Methodist Debakey Cardiovasc J. 2013 Jul-Sep;9(3):137-41. doi: 10.14797/mdcj-9-3-137.'}, {'pmid': '11270700', 'type': 'RESULT', 'citation': 'Luechinger R, Duru F, Scheidegger MB, Boesiger P, Candinas R. Force and torque effects of a 1.5-Tesla MRI scanner on cardiac pacemakers and ICDs. Pacing Clin Electrophysiol. 2001 Feb;24(2):199-205. doi: 10.1046/j.1460-9592.2001.00199.x.'}, {'pmid': '24851058', 'type': 'RESULT', 'citation': 'Ferreira AM, Costa F, Tralhao A, Marques H, Cardim N, Adragao P. MRI-conditional pacemakers: current perspectives. Med Devices (Auckl). 2014 May 7;7:115-24. doi: 10.2147/MDER.S44063. eCollection 2014.'}], 'seeAlsoLinks': [{'url': 'http://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?NCAId=289&proposed=N&utm', 'label': 'MagnaSafe Registry. Summary of the MagnaSafe Protocol.'}, {'url': 'https://www.radiology.wisc.edu/wp-content/uploads/2018/11/MRI_Safety_Subcomittee_on_Pacemakers_Memo_2018rev.pdf', 'label': 'University of Wisconsin-Madison. MRI Safety Subcommittee on Pacemakers: 2018 Revision. Madison (WI): University of Wisconsin-Madison, Department of Radiology'}, {'url': 'https://www.dicardiology.com/content/initial-data-presented-worlds-first-mri-safe-pacemaker', 'label': "Initial data presented on world's first MRI-safe pacemaker. DAIC DiCardiology. 2008 Sep 1 \\[cited 2025 Jun 21\\]"}, {'url': 'https://s.mriquestions.com/uploads/3/4/5/7/34572113/muthalalyradiol.2018180285.pdf', 'label': 'MRI Safety in Patients with Cardiac Implantable Electronic Devices: A Review. Radiology. 2018'}]}, 'descriptionModule': {'briefSummary': 'This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.', 'detailedDescription': 'Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic devices (CIEDs), particularly those with mixed-lead systems, remains a significant clinical concern. This report investigates the safety and efficacy of MRI in such patients, where generators and leads originate from different manufacturers and are not officially deemed MRI-conditional.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Average age of patients are 82 years old. All 100% of RA leads and devices were manufactured by Abbott; 31% of RV leads were manufactured by Boston Scientific, with the remaining 69% of RV leads by Medtronic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have a mixed-lead CIED\n* clinical relevant MRI\n\nExclusion Criteria:\n\n* same manufactured CIED'}, 'identificationModule': {'nctId': 'NCT07155135', 'acronym': 'MRIMLD', 'briefTitle': 'Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices', 'organization': {'class': 'INDUSTRY', 'fullName': 'Socal Heart'}, 'officialTitle': 'Magnetic Resonance Imaging Safety in Patients With Non-Conditional, Mixed-Manufacturer Cardiac Implantable Electronic Devices', 'orgStudyIdInfo': {'id': '2025818'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with mixed-lead Cardiac Implantable Electronic Devices', 'description': "Patients recieved clinical relevant MRI's. Patients are checked for complications post-MRI.", 'interventionNames': ['Diagnostic Test: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DIAGNOSTIC_TEST', 'description': "Magnetic resonance imaging (MRI) is a vital diagnostic tool in modern medicine due to its ability to produce detailed images of the body's internal structures without using ionizing radiation.", 'armGroupLabels': ['Patients with mixed-lead Cardiac Implantable Electronic Devices']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Heart Specialists', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}], 'overallOfficials': [{'name': 'Babak Tashakkor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Southern California Heart Specialists'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared due to privacy.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Socal Heart', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'First Author', 'investigatorFullName': 'Ryka Tashakkor', 'investigatorAffiliation': 'Socal Heart'}}}}