Safety of Magnetic Resonance Imaging in Patients With Pacemakers and Defibrillators

Completed

Conditions studied: Conditions Requiring Diagnostic Evaluation

In brief

Pacemakers and ICD's have traditionally been accepted as contraindications to MRI due to safety concerns. Recent work in our laboratory as well as our pilot study of approximately 500 patients has shown the safety of most contemporary implanted rhythm management devices in the MRI environment given appropriate precautions. Because the investigators have completed testing in animals weighing as little as 80 lbs. without incident, the investigators feel they can safely image children at this weight or greater (Circulation 2004; 110:475-482). The goal of this study is to expand on our pilot study and to develop a protocol, consistent with the Department of Health and Human Services (DHHS) requirements, that will increase our safety experience with clinically indicated MR imaging in patients with implanted cardiac pacemakers and ICD's. This is a cohort study. One thousand seven hundred patients with a clinical need for MRI will be recruited. Risks and Benefits associated with Magnetic Resonance (MR) imaging in the setting of implantable devices will be discussed and informed consent obtained. The type of device and leads will be ascertained. Patients will be monitored by a physician or a Registered Nurse (RN) with ACLS certification and familiarity with ICD/Pacemaker programming during the study. When imaging children who meet age and weight criteria, a physician will be present during the entire study. Fellow and attending radiology and electrophysiology support will be available in house in all cases. Standard device testing including battery voltages, thresholds, sensing and lead impedances will be measured.

Key facts

Study ID

NCT02227004

Run by

Johns Hopkins University

People needed

1275

Starts

2011-12-30

Expected to finish

2015-01-22

Last updated by the study team

2021-04-20

Who can join

Age: 9 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with an absolute clinical need for MR imaging and PPM (year 1996 model or later) or ICD's (year 2000 or later)

You may not qualify if…

• Inclusion: Patients with an absolute clinical need for MR imaging and PPM (year 1996 model or later) or ICD's (year 2000 or later)
• Exclusion:
• Patients with pacemaker models before 1996 and ICD models before year 2000.
• Pacemaker defendant patients with ICD.
• Patients who weighing less than 80 lbs.
• Patients less than 9 years old
• Patients who complete the MRI standard screening form and are deemed inappropriate for MRI for any reason
• Pregnant patients will be excluded in their first trimester and will not get gadolinium at any time during their pregnancy
• Patient with abandoned/capped leads or leads implanted <4 weeks unless the procedure is deemed critical by the referring physician and approved by the PI

Where it is running

• Johns Hopkins Hospital, Blalcok 5 MRI — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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