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Pacemaker patients can finally get MRIs safely, study shows

NCT ID NCT00433654

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a special pacemaker system designed to be safe during MRI scans. 484 people with slow heartbeats who needed a pacemaker took part. The pacemaker and its wires were implanted, and then some participants had an MRI of their head and lower back. The study found that the pacemaker worked well and caused few complications, even after the MRI.

What this could mean

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

Active substance
Implantable pacemaker and leads
What this could lead to
If successful, this could allow people with pacemakers to safely undergo MRI scans, improving diagnosis and monitoring of other health conditions.
What could go wrong
This was a device safety study, not a treatment for the underlying condition. Results may not apply to all pacemaker models or MRI types.

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

484 people

The number who actually took part.

Start date

Feb 2007

Finished

Aug 2010

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Subject has, or is at risk of having, a heart beat that is too slow and his/her doctor has determined he/she needs a pacemaker. * Subject available for follow-up at study center for length of study. * Subject able and willing to undergo elective MRI scanning without sedation. Exclusion Criteria: * Subject has, or is at risk of having, a heart beat that is too fast and his/her doctor has determined he/she needs an implantable cardioverter defibrillator (ICD). * Subject needs or will need another MRI-scan, other than those required by the study, during the required study follow-up period. * Pregnant women, or women of child bearing potential who are not on a reliable form of birth control. * Subject with exclusion criteria required by local law. * Subject who intends to participate in another clinical study during this clinical study.

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Conditions

The condition(s) this trial relates to.

Bradycardia

As listed by the trial registrant

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

Contacts and locations

Locations

  • Study site

    Redwood City, California, United States

  • Study site

    Salinas, California, United States

  • Study site

    Orlando, Florida, United States

  • Study site

    Peachtree City, Georgia, United States

  • Study site

    Des Moines, Iowa, United States

  • Study site

    Minneapolis, Minnesota, United States

  • Study site

    Kansas City, Missouri, United States

  • Study site

    St Louis, Missouri, United States

  • Study site

    Mineola, New York, United States

  • Study site

    Cincinnati, Ohio, United States

  • Study site

    Cleveland, Ohio, United States

  • Study site

    Erie, Pennsylvania, United States

  • Study site

    Knoxville, Tennessee, United States

  • Study site

    Charlottesville, Virginia, United States

  • Study site

    Norfolk, Virginia, United States

  • Study site

    Graz, Austria

  • Study site

    Linz, Austria

  • Study site

    Liège, Belgium

  • Study site

    Mons, Belgium

  • Study site

    Calgary, Alberta, Canada

  • Study site

    Victoria, British Columbia, Canada

  • Study site

    Kingston, Ontario, Canada

  • Study site

    London, Ontario, Canada

  • Study site

    Montreal, Quebec, Canada

  • Study site

    Sainte-Foy, Quebec, Canada

  • Study site

    Prague, Czechia

  • Study site

    Rouen, France

  • Study site

    Bad Nauheim, Germany

  • Study site

    Bonn, Germany

  • Study site

    Dortmund, Germany

  • Study site

    Dresden, Germany

  • Study site

    Essen, Germany

  • Study site

    Göttingen, Germany

  • Study site

    Hamburg, Germany

  • Study site

    Marburg, Germany

  • Study site

    München, Germany

  • Study site

    Ulm, Germany

  • Study site

    Asti, Italy

  • Study site

    Pescia, Italy

  • Study site

    Pietra Ligure, Italy

  • Study site

    Viterbo, Italy

  • Study site

    Amsterdam, Netherlands

  • Study site

    Nieuwegein, Netherlands

  • Study site

    Zurich, Switzerland

  • Study site

    London, United Kingdom

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