MRI Safety for Pacemaker and Defibrillator Patients

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Inappropriate for MRI

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of MRI scans (Magnetic Resonance Imaging) for individuals with implanted pacemakers or defibrillators, without the usual strict checks beforehand. Traditionally, these devices were considered risky for MRI, but new evidence suggests otherwise. The trial targets those with these heart devices who have a medical need for an MRI. Individuals with a pacemaker or defibrillator who require an MRI might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to important research that could change MRI safety protocols for many patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on the safety of MRI for patients with pacemakers or defibrillators.

What prior data suggests that MRI is safe for patients with pacemakers and defibrillators?

Research has shown that MRI scans can be safe for people with pacemakers and defibrillators if specific safety steps are followed. Studies indicate that patients with these devices can undergo MRI scans without major issues if their heart rhythm and vital signs are monitored during the scan. In some studies, even patients with older pacemaker or defibrillator systems had MRI scans without problems when safety measures were in place.

Improvements in device technology over time have also enhanced the safety of these scans. More than 2,000 patients with these devices have had successful MRI scans without strict pre-screening, suggesting that these scans can be done safely under the right conditions. However, a doctor experienced with pacemakers and defibrillators should be involved to ensure everything goes smoothly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the safety of performing MRIs on patients with pacemakers and defibrillators without the usual pre-screening processes. Typically, patients with these cardiac devices must undergo careful screening before an MRI due to potential risks, which can delay necessary imaging. This trial aims to show that MRIs can be safely conducted without pre-screening, potentially streamlining the process and making it faster and more accessible for patients needing diagnostic imaging. If successful, this could mean less hassle and shorter waiting times for patients without compromising safety.

What evidence suggests that MRI is safe for patients with pacemakers and defibrillators?

Research shows that MRI scans can be safely performed on people with pacemakers and defibrillators. Studies have found that even older models of these devices did not cause major problems when exposed to MRI. For instance, a large study found that over 90% of patients experienced no issues related to the MRI. Another study reported no significant changes in device function after an MRI. This trial will specifically evaluate the safety of MRI without pre-screening for patients with these cardiac devices, suggesting that with today's technology, MRI can be a safe choice for people with these implants. ^{1 3 4 6 7}

Who Is on the Research Team?

Henry R Halperin, MD/MA

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for patients with implanted pacemakers or defibrillators who need an MRI scan. Participants must meet standard MRI safety criteria, but unlike previous studies, they won't go through extra vetting because of their devices.

Inclusion Criteria

I have an ICD or pacemaker and need an MRI.

Exclusion Criteria

Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

MRI Procedure

Participants undergo MRI without prior vetting procedures, monitored by an electrophysiology nurse and MRI technologists

1 day

1 visit (in-person)

Follow-up

Participants complete a follow-up device evaluation to assess safety and device performance

1 to 6 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The study tests the safety of performing MRI scans on patients with certain heart devices without prior detailed device checks. It's a large study involving 1,700 participants to see if MRIs can be done safely under these new conditions.

How Is the Trial Designed?

Group I: Device: MRI no pre-screen Experimental Treatment 1 Intervention

Clinically Indicated MRI will be done in patients with cardiac devices (pacemakers and defibrillators). Patients will not be pre-screened prior to hospital visit.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

MRI scans at 1.5-Tesla do not pose a hazard to certain pacemakers and ICDs, as no significant magnetic field interactions or harmful heating were observed during the study.

Under specific conditions, including monitoring temperature changes and using certain RF power levels, these devices can be safely used during MRI procedures without affecting their functionality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac pacemakers and implantable cardioverter defibrillators: in vitro magnetic resonance imaging evaluation at 1.5-tesla. Shellock, FG., Fischer, L., Fieno, DS.[2014]

Recent studies indicate that patients with pacemakers or implantable cardioverter-defibrillators can safely undergo MRI under specific monitoring and reprogramming conditions, challenging the previous belief that these devices were absolute contraindications.

The involvement of device manufacturers in developing MRI-safe devices may expand the future use of MRI in patients with implanted cardiac devices, enhancing patient management options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance imaging in patients with pacemakers and implantable cardioverter-defibrillators: a systematic review]. Martins, RP., Baruteau, AE., Treguer, F., et al.[2018]

Recent studies indicate that certain pacemakers and implantable cardioverter-defibrillators (ICDs) may be safe for use during MRI scans, challenging the previous belief that these devices were absolute contraindications.

With evidence from hundreds of patients showing safe MR imaging under specific conditions, the potential diagnostic benefits of MRI may outweigh the risks for some patients with these devices, suggesting a need to reevaluate current imaging practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Roguin, A., Schwitter, J., Vahlhaus, C., et al.[2017]

The MagnaSafe Registry is a large-scale study aiming to evaluate the safety of performing MRI on patients with non-MRI-conditional cardiac devices, involving up to 1500 MRI examinations to assess adverse events and device changes.

As of August 2012, 701 MRI studies have been completed, indicating significant progress in understanding the risks associated with MRI in patients with implanted pacemakers or defibrillators, which could lead to more informed clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the risks of clinically indicated nonthoracic magnetic resonance imaging at 1.5 T for patients with pacemakers and implantable cardioverter-defibrillators: rationale and design of the MagnaSafe Registry. Russo, RJ.[2022]

The increasing number of patients with pacemakers and internal cardioverter-defibrillators (ICDs) raises concerns about their safety during MRI scans, as these devices are not FDA-approved for MRI use due to potential risks.

Despite the risks, emerging studies suggest that MRI can be performed safely in patients with implanted devices, and the paper proposes strategies to mitigate these risks based on current literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging, pacemakers and implantable cardioverter-defibrillators: current situation and clinical perspective. Götte, MJ., Rüssel, IK., de Roest, GJ., et al.[2022]

Magnetic resonance imaging (MRI) at 0.5 T can be safely conducted in patients with implanted cardiac pacemakers, as demonstrated in a study involving 44 patients and 51 MRI examinations, with no reported pacing dysfunctions.

The study showed that careful programming of pacemakers to an asynchronous mode and monitoring during the procedure effectively mitigated risks, with temperature increases at lead tips remaining within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging and cardiac pacemakers: in-vitro evaluation and in-vivo studies in 51 patients at 0.5 T. Sommer, T., Vahlhaus, C., Lauck, G., et al.[2017]

Recent advancements in understanding the risks and mechanisms of MRI interactions with cardiovascular devices have made it safer for patients with pacemakers and ICDs to undergo MRI scans.

The introduction of 'MR-conditional' devices has become the new standard of care, allowing for routine MRI use in these patients, although specific precautions must still be followed to ensure safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging safety in pacemaker and implantable cardioverter defibrillator patients: how far have we come? Nordbeck, P., Ertl, G., Ritter, O.[2018]

MRI is the preferred imaging method for soft tissue due to its superior capabilities, but it poses risks for patients with pacemakers or implantable cardiac defibrillators, as these devices can be adversely affected by MRI's magnetic fields and radio frequency energy.

Newly approved devices designed to enhance MRI safety for patients with pacemakers show promising initial data indicating they are safe to use in the MRI environment, potentially allowing more patients to benefit from MRI imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with magnetic resonance imaging-safe pacemakers : a review. Jung, W., Zvereva, V., Hajredini, B., et al.[2021]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1604267

Safety of MRI with Cardiac Devices We report the results of a large, prospective study that evaluated the safety of an MRI protocol in patients with legacy pacemaker or ICD systems.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3782320/

Safety Of Mris In Patients With Pacemakers And Defibrillators Therefore, this trial has shown that Medtronic's MR conditional pacing system appears to be safe and effective while exposed to EMI. The most recently developed ...

3. academic.oup.com academic.oup.com/europace/article/26/6/euae165/7699109

Safety of MRI in patients w/ cardiac devices & leads While there is a plethora of data on the safety of MRI in conditional and non-conditional implantable devices, there is a clear lack of safety ...

4. jacc.org jacc.org/doi/10.1016/j.jacep.2019.05.010

MRI Safety for Patients Implanted With the MRI Ready ICD ... The primary safety objective was >90% freedom from MRI scan-related complications. The primary efficacy objectives were absence of change in ...

5. onlinecjc.ca onlinecjc.ca/article/S0828-282X(21)00115-X/fulltext

2021 Update on Safety of Magnetic Resonance Imaging There is currently no published, externally validated data for the scanning of MRI-conditional pacemakers or defibrillators at 3 T. However, several CIEDs have ...

6. acc.org acc.org/Latest-in-Cardiology/Articles/2024/05/21/10/30/Current-State-of-MRI-With-Cardiac-Devices

Current State of MRI With Cardiac Devices Magnetic resonance imaging (MRI) examinations in patients with cardiac implantable electronic devices (CIEDs) are safe if safety protocols ...

7. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.107.187256

Safety of Magnetic Resonance Imaging in Patients With ... The patient's heart rhythm and vital signs should be monitored throughout the MR examination. A physician with pacemaker/ICD expertise should be ...