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

Trial Summary

What is the purpose of this trial?

This is a database study of clinically indicated MRIs on patients with permanent pacemakers and implantable cardioverter defibrillators.

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 data supports the effectiveness of the treatment MRI, Magnetic Resonance Imaging, for pacemaker/defibrillator patients?

Recent studies show that with advancements in technology and understanding, many patients with pacemakers or defibrillators can safely undergo MRI scans under specific conditions. These studies indicate that the diagnostic benefits of MRI can outweigh the risks for some patients, suggesting that MRI can be an effective imaging tool for individuals with these devices. ^{1 2 3 4 5}

Is MRI safe for patients with pacemakers or defibrillators?

Recent studies show that MRI can be performed safely on patients with pacemakers or defibrillators if specific precautions are taken, such as using 'MR-conditional' devices and proper monitoring. However, there are still potential risks, and the procedure should be done carefully to avoid complications. ^{2 4 5 6 7}

How is the MRI treatment for pacemaker/defibrillator patients different from other treatments?

This treatment is unique because it involves using MRI, which was previously considered unsafe for patients with pacemakers or defibrillators due to potential risks. Recent advancements have made it possible to safely perform MRIs on these patients by using 'MR-conditional' devices and following specific precautions, allowing for important diagnostic imaging that was not previously available. ^{2 4 8 9 10}

Research Team

Charles Henrikson, MD

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

MR imaging and cardiac pacemakers: in-vitro evaluation and in-vivo studies in 51 patients at 0.5 T. [2017]

2. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging safety in pacemaker and implantable cardioverter defibrillator patients: how far have we come? [2018]

3. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging, pacemakers and implantable cardioverter-defibrillators: current situation and clinical perspective. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cardiac pacemakers and implantable cardioverter defibrillators: in vitro magnetic resonance imaging evaluation at 1.5-tesla. [2014]

6. United States 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. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Initial experience with magnetic resonance imaging-safe pacemakers : a review. [2021]

8. France pubmed.ncbi.nlm.nih.gov

[Magnetic resonance imaging in patients with pacemakers and implantable cardioverter-defibrillators: a systematic review]. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Determining the risks of magnetic resonance imaging at 1.5 tesla for patients with pacemakers and implantable cardioverter defibrillators. [2017]

10. England 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. [2021]