The MagnaSafe Registry: Determining the Risks of Magnetic Resonance Imaging (MRI) in the Presence of Pacemakers and Implantable Cardioverter Defibrillators (ICDs)

Completed

Conditions studied: Need for MRI Imaging With Pacemaker or, Implantable Cardioverter Defibrillator Implanted

In brief

This study will create a registry of patients with pacemakers and implantable ICDs who will undergo clinically indicated MRI and will document the incidence of any adverse events or changes in device parameters that might be associated with the procedure.

Key facts

Study ID

NCT00907361

Run by

Scripps Health

People needed

2039

Starts

2009-04-01

Expected to finish

2014-06-01

Last updated by the study team

2015-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female 18 years or older
• Able to provide informed consent
• Permanent implanted pacemaker or ICD
• Strong clinical indication for MRI; in the clinical setting where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology as determined by the ordering physician.
• Patient is scheduled for non-thoracic MRI (joint, extremity, brain, pelvis, cervical, and lumbar or sacral spine)

You may not qualify if…

• Metallic objects that represent a contraindication to MR imaging, including: intra-orbital or intra-ocular retained metal fragments, and intracranial vascular clips and coils
• Claustrophobia unresponsive to pre-procedure sedatives
• Morbid obesity (abdominal diameter >60 cm)
• ICD or pacemaker generator placement prior to 2002
• ICD and pacing dependent
• Pregnancy
• Device generator battery voltage at elective replacement index (ERI)
• Presence of active implantable medical device (other than pacemaker or ICD)
• 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 (approved by the FDA for exposure to MRI).

Where it is running

• Providence St. Joseph Medical Center — Burbank, California, United States
• Scripps Clinic/Green Hospital — La Jolla, California, United States
• Scripps Memorial Hospital — La Jolla, California, United States
• UCLA Cardiac Arrhythmia Center — Los Angeles, California, United States
• Spectrum Clinical Research — Moreno Valley, California, United States
• University of California, San Diego — San Diego, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Aventura Hospital and Medical Center — Aventura, Florida, United States
• Northern Indiana Research Alliance — Fort Wayne, Indiana, United States
• Baptist Health Lexington — Lexington, Kentucky, United States
• Providence Heart Institute — Southfield, Michigan, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• The Valley Hospital — Ridgewood, New Jersey, United States
• Advanced Cardiovascular Imaging — New York, New York, United States
• Oklahoma Heart Research and Education Foundation — Tulsa, Oklahoma, United States
• Abington Health System — Abington, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• The Methodist Hospital — Houston, Texas, United States
• Intermountain Medical Center — Murray, Utah, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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