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Heart device patients may soon get full-body MRI scans without worry

NCT ID NCT06038123

Disease control Sponsor: Medtronic Cardiac Rhythm and Heart Failure 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether Medtronic SureScan pacemakers and defibrillators are safe during 3.0T MRI scans anywhere on the body. 64 adults with these devices received an MRI scan and were followed for one month. The goal was to see if any serious problems occurred, such as device malfunction or heart rhythm issues.

What this could mean

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

Active substance
Medtronic SureScan CIED system (pacemaker or defibrillator)
What this could lead to
If successful, this could confirm that people with these heart devices can safely undergo 3.0T MRI scans without restrictions on which body part is scanned.
What could go wrong
This is a small, completed study with only 64 participants. Results may not apply to all patients or other device brands. MRI-related risks like device malfunction or heart rhythm issues remain possible.

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

64 people

The number who actually took part.

Started

Nov 2023

Finished

Oct 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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

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: * Subjects who were implanted an SureScan system CIED over 6 weeks at the time of signing ICF. * Subjects who are able and willing to undergo elective MRI scanning without sedation. * Subjects who were implanted an SureScan system CIED in the pectoral region. * Subjects who are geographically stable and available for follow-up at the study site for the length of the study. * Subjects who are at least 18 years of age (or older, if required by local law). Exclusion Criteria: * Subjects who require a legally authorized representative to obtain informed consent. * Subjects with abandoned or capped leads. * Subjects who require an indicated MRI scan, other than those specifically described in the China CIED 3.0T MRI performance study, before the 1-month post-MRI follow-up. * Subjects with a non-MRI compatible device (such as neurostimulators) or material implant (e.g., non-MRI compatible sternal wires, neurostimulators, biostimulators, metals or alloys). * Subjects with medical conditions that preclude the testing required by the CIP or limit study participation. * Subjects who are enrolled or intend to participate in another clinical trial (of an investigational drug or device, new indication for an approved drug or device, or requirement of additional testing beyond standard clinical practice) during the SureScan study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic study manager. * Female patient who is pregnant, or of childbearing potential and not on a reliable form of birth control. Women of childbearing potential are required to have a negative pregnancy test within seven (7) days prior to device implant.

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Conditions

The condition(s) this trial relates to.

Bradycardia heart failure Tachycardia

As listed by the trial registrant

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

Bradycardia Heart failure Tachycardia

Contacts and locations

Locations

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, China

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, China

  • Shanghai Tongren Hospital

    Shanghai, Shanghai Municipality, China

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi, China

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, China

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