MRI Safety for Pacemaker Lead Fracture

Overseen By Jonathan Derr, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lancaster General Hospital

Disqualifiers: Inappropriate for MRI, Under 18

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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the safety and efficacy of MRI scanning in patients with fractured or abandoned endocardial leads. Specifically, the investigators aim to provide community-acquired data that can be used in Medicare and Medicaid coverage determinations and to investigate whether patients with fractured or abandoned leads can safely be scanned using an MRI and to evaluate the impact of MRI availability on patient care in this population. This study also aims to validate similar studies conducted by Mayo Clinic, the Hospital of the University of Pennsylvania and Johns Hopkins Medicine that employ MRI in the abandoned lead patient population.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment MRI for pacemaker lead fracture?

Recent studies show that MRI can be safely performed on patients with pacemakers if specific precautions are taken, such as device reprogramming and careful monitoring. Advances in technology have led to the development of 'MR-conditional' devices, which are designed to be safe in the MRI environment, allowing more patients to undergo MRI without significant risks. ^{1 2 3 4 5}

Is MRI safe for patients with pacemakers?

MRI can be risky for patients with pacemakers due to potential heating of the pacemaker lead and electromagnetic interference. However, some newer pacemaker systems, like the Medtronic EnRhythm MRI SureScan, have been designed and tested for safer use in MRI environments, although they are not yet considered completely 'MRI-safe' or 'MRI-compatible' by the FDA. ^{6 7 8 9 10}

How is MRI treatment unique for patients with pacemaker lead fractures?

MRI is unique for patients with pacemaker lead fractures because it allows for detailed imaging without surgery, but it requires special 'MR-conditional' pacemakers designed to be safe in the MRI environment. This is different from traditional treatments that might avoid MRI due to safety concerns with standard pacemakers. ^{1 4 6 7 11}

Research Team

Sandeep Bansal, MD

Principal Investigator

The Heart Group

Eligibility Criteria

This trial is for English or Spanish speaking adults with a broken or unused heart device lead who need an MRI scan. It's not for those unsuitable for MRI due to other reasons, or anyone under 18.

Inclusion Criteria

I have a heart device and need an MRI despite having a non-working lead.

I can speak and understand English or Spanish and can sign the consent form.

Exclusion Criteria

Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason other than abandoned or fractured endocardial, or epicardial lead.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Scanning

Participants undergo MRI scanning to evaluate safety and efficacy in patients with fractured or abandoned endocardial leads

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and symptoms post-MRI scan

4 weeks

Longitudinal Follow-up

Participants may re-enroll for subsequent MRI scans to understand utilization and safety over time

7 years

Treatment Details

Interventions

• MRI

Trial Overview The study tests the safety and effectiveness of MRI scans in patients with fractured or abandoned leads from pacemakers or defibrillators, aiming to influence Medicare/Medicaid coverage decisions.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

Patient will receive MRI

Who Is Running the Clinical Trial?

Lancaster General Hospital

Lead Sponsor

Trials

25

Recruited

4,100+

Findings from Research

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 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 36 patients with MR conditional pacemakers, undergoing heart MRI at 1.5 Tesla was found to be safe, with no adverse events reported during or after the procedure.

While some patients experienced increases in pacing capture thresholds (PCT) after the MRI, these changes were not clinically significant, indicating that the MRI did not adversely affect the function of the pacemaker system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe performance of magnetic resonance of the heart in patients with magnetic resonance conditional pacemaker systems: the safety issue of the ESTIMATE study. Wollmann, CG., Thudt, K., Kaiser, B., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. France pubmed.ncbi.nlm.nih.gov

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

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

Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. [2017]

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

Magnetic resonance imaging in patients with recently implanted pacemakers. [2018]

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

Safe magnetic resonance image scanning of the pacemaker patient: current technologies and future directions. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safe performance of magnetic resonance of the heart in patients with magnetic resonance conditional pacemaker systems: the safety issue of the ESTIMATE study. [2021]

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

3.0 T magnetic resonance imaging scanning on different body regions in patients with pacemakers. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in patients with temporary external pacemakers. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Safety of magnetic resonance imaging of patients with a new Medtronic EnRhythm MRI SureScan pacing system: clinical study design. [2021]

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

Evaluating MRI-compatible pacemakers: patient data now paves the way to widespread clinical application? [2017]