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MRI safety for broken heart leads: small study ends early

NCT ID NCT04478773

Knowledge-focused Sponsor: Lancaster General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study aimed to see if MRI scans are safe for people with broken or unused wires (leads) from pacemakers or defibrillators. It enrolled 18 participants and monitored for side effects like chest pain or heart rhythm problems. The study was terminated early, so the findings are limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors safely offer MRI scans to more patients with broken or unused heart device leads.
What could go wrong
The study was terminated early and had only 18 participants, so results are limited and may not apply to everyone. MRI in these patients still carries unknown risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Dec 2020

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Patients implanted with or without an ICD or pacemaker and with a fractured or an abandoned or non-functional endocardial lead, and who have a clinical need for MR imaging * Patients are English or Spanish speaking and able to review and sign the consent 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. * Patients less than 18 years of age

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Conditions

The condition(s) this trial relates to.

impulse control disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ICD Pacemaker electrode lead fracture

Contacts and locations

Locations

  • Lancaster General Health

    Lancaster, Pennsylvania, 17602, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.