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

4500 Participants Needed

Trial Summary

What is the purpose of this trial?

Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary. Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting. This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.

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

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

Is MRI safe for patients with pacemakers and defibrillators?

Recent studies show that MRI can be performed safely on patients with pacemakers and defibrillators if specific precautions are taken, such as proper monitoring and device adjustments. Newer 'MR-conditional' devices are designed to be safe in MRI environments, but it's important to follow guidelines to avoid risks. ^{2 5 6 7 8}

How is the MRI treatment unique for pacemaker and defibrillator patients?

MRI is unique for pacemaker and defibrillator patients because it was historically considered unsafe due to risks like device malfunction or heating. However, advancements have led to 'MR-conditional' devices that allow these patients to safely undergo MRI with specific precautions, making it a viable option when other diagnostic methods are insufficient. ^{2 7 9 10 11}

Research Team

Henry R Halperin, MD/MA

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

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]

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]

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 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]

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. Germany pubmed.ncbi.nlm.nih.gov

An eight-year prospective controlled study about the safety and diagnostic value of cardiac and non-cardiac 1.5-T MRI in patients with a conventional pacemaker or a conventional implantable cardioverter defibrillator. [2020]

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

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

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

9. France pubmed.ncbi.nlm.nih.gov

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of magnetic resonance imaging in patients with implanted cardiac prostheses and metallic cardiovascular electronic devices. [2012]

11. England pubmed.ncbi.nlm.nih.gov

Unexpected asystole during 3T magnetic resonance imaging of a pacemaker-dependent patient with a 'modern' pacemaker. [2009]