MRI Safety for Pacemaker/Defibrillator Patients

Recruiting at 1 trial location

Overseen By Charles Henrikson, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Old pacemakers, Pacemaker dependent, Underweight, Pregnant, others

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: 1

10000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety of MRI scans (Magnetic Resonance Imaging) for individuals with pacemakers or defibrillators. Researchers seek to determine how MRI affects these devices, focusing on pacemaker models made in 1996 or later and defibrillator models from 2000 or later. The trial seeks participants who require an MRI for medical reasons and have these specific device models. This study is crucial for ensuring that MRIs can be safely used without harming the devices or patients. As an unphased trial, it offers participants the chance to contribute to vital safety research that could benefit many with similar medical devices.

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

The trial information does not specify whether you need to stop taking your current medications.

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

In a large study, researchers found MRIs to be safe for patients with pacemakers or defibrillators if certain safety steps are followed. Another study supported this finding, showing that modern pacemaker and defibrillator systems might be safe during an MRI. However, there is still insufficient information on the safety of MRIs with older or non-standard devices. While MRIs can be safe if guidelines are followed, patients should consult their doctors to understand their specific risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to evaluate the safety of MRI scans for patients with pacemakers or defibrillators. Traditionally, people with these devices have been advised against MRIs due to potential risks, such as device malfunction or heating of the device. This study is exploring whether it's possible for these patients to safely undergo MRI, which could significantly broaden their diagnostic options. If successful, this could lead to more comprehensive and non-invasive imaging possibilities for patients with these cardiac devices, allowing for better overall care.

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

Research has shown that MRI scans can be safe for individuals with pacemakers and implantable cardioverter defibrillators (ICDs). In this trial, patients with a PPM or ICD will undergo a clinically indicated MRI to assess safety. A large study found that a special MRI method did not harm these patients. Another study demonstrated that Medtronic's MR conditional pacing system was safe and effective during an MRI. The aim is to prevent any problems during the MRI scan. Overall, evidence supports that MRI scans, when conducted properly, can be safe for people with these devices. ^{1 2 5 6 7}

Who Is on the Research Team?

Charles Henrikson, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for patients who need an MRI and have a pacemaker (made after 1996) or defibrillator (made after 2000). It's not for pregnant women in their first trimester, those with old or certain problematic heart device leads, people under 80 lbs, or anyone unsuitable for MRI.

Inclusion Criteria

You have a medical condition that requires magnetic resonance imaging (MRI) or a pacemaker/defibrillator made after a certain year.

Exclusion Criteria

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

You rely on a pacemaker or implantable cardioverter-defibrillator (ICD) to regulate your heart.

I am not in my first trimester of pregnancy and understand I cannot receive gadolinium.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Procedure

Patients undergo clinically indicated MRI with continuous monitoring and device interrogation

During MRI scan

1 visit (in-person)

Post-MRI Follow-up

Participants are monitored for safety and device performance after MRI

1-6 weeks

Follow-up in device clinic

What Are the Treatments Tested in This Trial?

Interventions

• MRI

Trial Overview The study is examining the safety and outcomes of performing medically necessary MRIs on patients with newer models of permanent pacemakers and implantable cardioverter defibrillators.

How Is the Trial Designed?

Group I: the study Experimental Treatment 1 Intervention

Patients with a PPM or ICD getting a clinically indicated MRI

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

In a study of 356 patients with cardiac pacemakers, undergoing cranial MRI at 1.5 Tesla was found to be safe, with no complications or arrhythmias reported during the scans.

Long-term follow-up (up to 12 months) showed no significant changes in pacemaker function, including pacing capture and sensing thresholds, indicating that MRI does not adversely affect pacemaker performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate and 12 months follow up of function and lead integrity after cranial MRI in 356 patients with conventional cardiac pacemakers. Muehling, OM., Wakili, R., Greif, M., et al.[2021]

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]

In a study of 109 patients with pacemakers and implantable cardioverter-defibrillators who underwent 125 MRIs, there were no serious complications such as device failures or induced arrhythmias, indicating that MRI is safe for these patients.

While some minor changes in device parameters were observed during MRI, such as slight decreases in battery voltage and pacing threshold increases, these changes were not clinically significant and comparable to those in a control group that did not undergo MRI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. Cohen, JD., Costa, HS., Russo, RJ.[2017]

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]

Citations

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

Safety of Magnetic Resonance Imaging in Patients with ... 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 magnetic resonance imaging in patients with cardiac ... 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. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(20)30859-6/fulltext

Safety of magnetic resonance imaging scanning in patients ... The purpose of this study was to evaluate the safety and effectiveness of ICDs and CRT-D systems with quadripolar LV leads after an MRI scan.

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 MRI examinations in patients with CIEDs are safe when rigorous protocols are followed regardless of the type of CIED.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3410537/

Modern Pacemaker and Implantable Cardioverter ... Conclusions. These data suggest that certain modern pacemaker and ICD systems may indeed be MRI safe. This may have major clinical implications for current ...