Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices
NCT ID: NCT07155135
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
16 participants
OBSERVATIONAL
2021-07-01
2025-08-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
NCT02888353
Safety of Cardiac Pacemakers in 1.5T Tesla MRI
NCT00336011
Safety and Clinical Outcomes of Magnetic Resonance Imaging in Patients With Cardiac Implantable Electrical Devices
NCT03016429
Study Evaluating the Use of MRI on CMS Patients
NCT02513056
Assessment Of MRI In Patients With Implanted Cardiac Devices
NCT02815384
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with mixed-lead Cardiac Implantable Electronic Devices
Patients recieved clinical relevant MRI's. Patients are checked for complications post-MRI.
MRI
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MRI
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* clinical relevant MRI
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Socal Heart
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ryka Tashakkor
First Author
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Babak Tashakkor, MD
Role: STUDY_DIRECTOR
Southern California Heart Specialists
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southern California Heart Specialists
Pasadena, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
MagnaSafe Registry. Summary of the MagnaSafe Protocol.
University of Wisconsin-Madison. MRI Safety Subcommittee on Pacemakers: 2018 Revision. Madison (WI): University of Wisconsin-Madison, Department of Radiology
Initial data presented on world's first MRI-safe pacemaker. DAIC DiCardiology. 2008 Sep 1 \[cited 2025 Jun 21\]
MRI Safety in Patients with Cardiac Implantable Electronic Devices: A Review. Radiology. 2018
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2025818
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.