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MRI access for pacemaker patients: landmark safety study launches

NCT ID NCT07189728

Knowledge-focused Sponsor: The Scripps Research Institute 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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This registry will enroll 1,500 adults with pacemakers or defibrillators to see if it is safe to have an MRI in situations not yet well studied, such as with older leads or at higher magnetic strengths. Participants will be monitored for heart rhythm changes and other complications during and after the scan. The goal is to provide evidence that could expand MRI access for millions of patients who currently may be denied this imaging.

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 study could expand MRI access for many patients with pacemakers or defibrillators who are currently denied scans.
What could go wrong
This is an observational registry, not a treatment trial. It only collects data on risks and may not change practice if no clear safety signal emerges.

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.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2031

An estimate. End dates often move.

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.

Who is studied

The proposed study, the MagnaSafe-2 Registry, is a prospective, multicenter registry designed to determine the risks of MRI in three groups of patients presently without access to clinically indicated MRI and not previously addressed in clinical investigations or peer-reviewed literature. The three groups of patients presently without adequate access to MRI are those with (1) a patient with CIED system scheduled for MRI at a magnet field strength of 3-tesla and labelled NMRC at that field strength, (2) a patient with an NMRC system due to a "mixed-vendor" or a same vendor "mixed-component" system scheduled for imaging at 1.5-tesla or 3-tesla, and (3) a patient with an MRC or NMRC pacing system and an abandoned lead, epicardial lead, fractured lead or subcutaneous array scheduled for clinically indicated MRI at a field strength of 1.5-tesla.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 will be included in the registry if they fulfill all the following criteria: 1. Age of 18 years or older 2. Able to provide informed consent for entry in the research registry 3. Have a CIED from any manufacturer implanted after 2001 4. Have cardiac leads from any manufacturer without an implant date limitation 5. Documentation that the patient's ordering physician has determined that an MRI at 1.5-tesla or 3.0-tesla of any anatomic region is clinically indicated without an acceptable alternative imaging technology 6. The patient is scheduled for that imaging procedure 7. MRI will be performed for clinical purposes, and not for the purpose of entry into this research protocol 8. In addition, groups within the protocol require that an enrolled patient will have: 1. An NMRC CIED scheduled for MRI at 3.0-tesla with a CIED that is not MRC at that field strength. 2. A "mixed-vendor" or same vendor "mixed-component" system that is NMRC because the generator and lead combination are not labeled as MRC for use in the MR-environment. 3. A CIED and abandoned lead, a fractured cardiac lead, an epicardial lead, or a subcutaneous array. Exclusion Criteria: Patients will not be included in the registry if they fulfill any of the following criteria: <!-- --> 1. A generator battery at the elective replacement indicator (ERI) 2. Renal insufficiency (GFR \<45 cc/min) 3. In addition, all standard clinical exclusion criteria for MRI in patients without a cardiac device will be observed. 4. Standard clinical exclusion criteria include pregnancy, severe claustrophobia (not responsive to pre-procedure medications), morbid obesity (abdominal diameter of greater than 60 cm), and the presence of ferro-magnetic metallic objects (such as intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils) \-

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As listed by the trial registrant

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

Implantable cardioverter defibrillator (ICD) Mri imaging Pacemakers

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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