University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices

Completed

Conditions studied: MRI, Pacemaker, Defibrillator

In brief

A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

Key facts

Study ID

NCT02548819

Run by

University Health Care System, Augusta, Georgia

People needed

220

Starts

2015-09-01

Expected to finish

2017-03-01

Last updated by the study team

2017-06-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female 18 years or older
• Informed consent can be provided by patient or medical power of attorney
• Presence of implanted pacemaker or ICD
• MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
• Non-cardiac/non-thoracic MRI ordered

You may not qualify if…

• Presence of metallic objects that represent a contraindication to MR imaging
• Morbid obesity which results in body contact with the magnet façade
• Pacemaker or ICD generator implanted prior to 2002
• ICD patients who are pacing dependent
• Pregnancy
• Device generator at ERI (elective replacement interval)
• Presence of other active implanted medical device
• Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
• Presence of implanted cardiac device in the abdominal position
• Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
• Pacemaker or ICD implanted less than 6 weeks prior to MRI scan

Where it is running

• University Hospital — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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