Magnetic Resonance Imaging (MRI) in Patients With Pacemakers and Implanted Cardioverter Defibrillators
Enrolling by invitation · Not applicable
Conditions studied: Device:MRI
In brief
Ferromagnetic Implants such as permanent pacemakers (PPM's) and Implantable Cardioverter Defibrillators (ICD's) have traditionally been accepted as contraindications to Magnetic Resonance Imaging (MRI) due to safety concerns. Over the past several years, MRI safety has been established in patients with pacemakers or ICD's but only in patients in whom strict vetting procedures were implemented. These vetting procedures were initially developed to eliminate devices, leads and device/lead circumstances thought to carry increased risk. Over recent years however, objective scientific evidence has failed to support this concern raising the question as to whether or not these vetting procedures are necessary. Investigators hypothesize that in view of the existing objective scientific data, evolution of device technology and the fact that the investigators have scanned more than 2,000 devices safely (RPN03-08-11-12 and 00051707) ICD's and pacemakers and device circumstances previously excluded from MRI protocols can be safely scanned without prior vetting. This is a prospective, non randomized, cohort study. Seventeen Hundred participants with an implanted ICD or pacemaker and a clinical need for MRI will be included in the study. Unlike previous studies where strict vetting procedures were implemented pre-procedure, All patients with a pacemaker or ICD and clinical need for an MRI will be eligible for inclusion in the study provided participants meet standard MRI inclusion/exclusion safety criteria.
Key facts
- Study ID
- NCT02888353
- Run by
- Johns Hopkins University
- People needed
- 4500
- Starts
- 2015-12-01
- Expected to finish
- 2027-02-01
- Last updated by the study team
- 2025-12-15
Who can join
Age: 9 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients implanted an ICD or pacemaker who have a clinical need for MR imaging
You may not qualify if…
- Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason
Where it is running
- Johns Hopkins Hospital, Zayed 5 MRI — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.