Pacemaker patients can finally get MRIs safely, study shows
NCT ID NCT00433654
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bradycardia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Why do some children arrive at the ER with a racing or skipping heart?
- A temporary wire that keeps hearts beating on cue
- Can a video get heart device patients moving more?
- Why do some hearts slow down after pulsed field ablation?
- Which pacing target keeps the heart stronger? a trial aims to find out
- Can a pacemaker slip in through the neck vein?