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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety of MRI scans (Magnetic Resonance Imaging) for individuals with broken or non-working pacemaker wires. Researchers aim to determine if access to MRI scans can improve care for these patients. Participants must have a pacemaker or similar device with a faulty lead and require an MRI for their health care. The goal is to ensure that individuals with these specific issues can safely use MRI technology, potentially aiding treatment decisions. As an unphased study, this trial provides a unique opportunity to contribute to research that could enhance MRI safety and care for patients with pacemaker issues.

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 prior data suggests that MRI is safe for patients with fractured or abandoned pacemaker leads?

Research has shown that having an MRI with broken or unused pacemaker wires can be risky because the wires might heat up during the scan. However, studies have found that MRI can be done safely in some cases. For instance, one large study reported no serious side effects in over 900 MRI exams on patients with these types of wires.

Current guidelines classify unused wires as a moderate risk and broken wires as a high risk. Although some evidence suggests MRI can be safe in these situations, caution is still necessary. Those considering joining a trial like this should discuss personal risks and benefits with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the safety of using MRI scans in patients who have a pacemaker lead fracture. Traditionally, patients with pacemaker leads are often advised to avoid MRIs due to the risk of interfering with the device's function. This trial is significant because it seeks to determine if MRIs can be safely used in these patients, potentially expanding diagnostic options and improving patient care. If successful, this could mean more accurate and timely diagnoses for individuals with pacemaker lead fractures without compromising their safety.

What evidence suggests that MRI is effective for patients with pacemaker lead fractures?

Research has shown that MRI scans can be safe for people with broken or inactive pacemaker wires. Studies involving patients with inactive wires found no serious safety issues during MRI scans. For example, one study examined 139 patients with 243 inactive wires, and another study involved 40 patients with similar conditions. Both studies reported no harmful effects. Although less information exists about broken wires, current evidence suggests that MRI scans might not be harmful if conducted carefully. In this trial, participants will undergo an MRI to further evaluate its safety for those with pacemaker lead fractures. Overall, these findings suggest that MRI could be a safe option for people with certain types of pacemaker wires. ^{5 6 7 8 9}

Who Is on the Research Team?

Sandeep Bansal, MD

Principal Investigator

The Heart Group

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11200101/

Safety of magnetic resonance imaging in patients with cardiac ...

Existing publications did not report any relevant adverse events for MRI in patients with abandoned and/or epicardial leads if performed according to strict ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/circ.142.suppl_3.12916

Abstract 12916: Outcomes of Magnetic Resonance ...

This study examined the clinical impact of lead length, lead location, and lead shape on patient outcomes in patients with pacemakers/ICDs and fractured or ...

3.

onlinecjc.ca

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

2021 Update on Safety of Magnetic Resonance Imaging

There are no clinical data on safety of MRI in patients with fractured leads or lead extenders. Because existing clinical data suggest the absence of harm, MRI ...

4.

pmc.ncbi.nlm.nih.gov

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

Safety Of Mris In Patients With Pacemakers And Defibrillators

In this paper, we discuss the potential adverse effects of MRIs in patients with cardiac devices, review key studies that have addressed strategies to limit ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S1097664724009864

SCMR expert consensus statement for cardiovascular ...

Recent studies of 139 patients with 243 abandoned leads undergoing 200 MRIs [41] and of 40 patients with abandoned leads [35] showed no serious safety events, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11211945/

MRI in Patients with Cardiovascular Implantable Electronic ...

Patients with abandoned leads or lead fragments are considered at risk because of the unpredictable effects of lead tip heating during MRI and, ...

7.

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

Abandoned leads have been downgraded to intermediate risk in recent guidelines whereas fractured leads are still considered high risk. In these ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S1050173821000852

Magnetic resonance imaging safety in patients with cardiac ...

In some instances at our institution, MRI has been safely performed in patients with a permanent active fixation lead attached to an externalized permanent ...

9.

academic.oup.com

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

Safety of magnetic resonance imaging in patients with cardiac ...

In summary, the present analysis of more than 900 MRI examinations did not reveal any serious adverse effects in patients with abandoned and/or ...