Safety of Magnetic Resonance Imaging With Patients Who Have Mixed Lead Cardiac Implantable Electronic Devices

NCT07155135 | Completed

• 1 other identifier: 2025818
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is looking at the safety and efficacy of using MRIs with patients who have cardiac implantable electronic devices.

Conditions

Safety of MRI

Keywords

cardiac implantable electronic devices; CIED; MRI; Magnetic Resonance Imaging; safety

Outcome Measures

Primary Outcomes (3)

• Evaluation of Changes in Device Battery Voltage (Volts)

  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.

  Immediately Prior to MRI and Immediately after MRI

• Evaluation of Changes in Lead Impedance (Ohms)

  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.

  Immediately Prior to MRI and Immediately after MRI

• Evaluation of Changes in Lead Threshold (Voltage) Before and After MRI

  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.

  Immediately Prior to MRI and Immediately after MRI

Secondary Outcomes (1)

• Evaluation of Changes in Patient Clinical Outcomes (Rhythm, Symptoms, Cardiac Arrest, or Death) Before and After MRI

  Immediately Prior to MRI and Immediately after MRI

Study Arms (1)

Patients with mixed-lead Cardiac Implantable Electronic Devices

Patients recieved clinical relevant MRI's. Patients are checked for complications post-MRI.

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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.

Patients with mixed-lead Cardiac Implantable Electronic Devices

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• have a mixed-lead CIED
• clinical relevant MRI

You may not qualify if:

• same manufactured CIED

Sponsors & Collaborators

• Socal Heart: lead

Study Sites (1)

Southern California Heart Specialists

Pasadena, California, 91105, United States

Location

Related Publications (14)

• 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.

  PMID: 28225684 RESULT

• 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.

  RESULT

• 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.

  RESULT

• 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: 39452284 RESULT

• 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: 29281579 RESULT

• 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: 28960745 RESULT

• 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: 17362687 RESULT

• 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: 10561087 RESULT

• 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: 781163 RESULT

• 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: 15944094 RESULT

• 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: 15618060 RESULT

• 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: 24066196 RESULT

• 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: 11270700 RESULT

• 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.

  PMID: 24851058 RESULT

Related Links

• 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

Study Officials

• Babak Tashakkor, MD

  Southern California Heart Specialists

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Author

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: September 4, 2025
• Study Start: July 1, 2021
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)