The MagnaSafe-2 Registry: Assessing the Risks of Magnetic Resonance Imaging in Three Patient Groups

SUMMARY OF THE CLINICAL PROTOCOL Background: The risks of Magnetic Resonance Imaging (MRI) at 1.5-tesla for patients with a non-MRI-conditional (NMRC) pacemaker have been documented, guidelines for clinical practice have been published by the Heart Rhythm Society, and the Medicare National Coverage Determination (NCD) has been modified to provide coverage for these patients (CAG-00399R4). However, for patients with an abandoned, epicardial, or fractured cardiac lead or subcutaneous array, with a "mixed-vendor" or same-vendor "mixed-component" CIED, or those undergoing MRI at 3.0-tesla with a device not labelled as MRI-conditional (MRC) for use at 3-tesla, the risks of MRI have not been determined. Hypothesis: For patients with an MRC or NMRC pacemaker or defibrillator and specific indications or circumstances not presently addressed, the risks of MRI do not increase. Purpose: The MagnaSafe-2 Registry is designed to determine the risks of MRI in patients with limited MRI access not previously addressed in peer-reviewed literature and to improve access for approximately 70% of whom are predicted to have a future clinical need for MRI. Study Design: A prospective registry of patients undergoing clinically indicated MRI. The protocol is being developed in collaboration with the FDA's Center for Devices and Radiological Health, and an Investigational Device Exemption is being requested for event reporting and monitoring. Also, "Coverage with Evidence Development (CED)" has been requested from CMS. Enrollment: Eligible patients are 18 years or older and have a MRC or NMRC pacemaker system from any manufacturer, (after 2001), with leads from any manufacturer (without date restriction), and if the ordering physician has determined that MRI is clinically indicated, the imaging method of choice, and NOT performed for the purpose of research. Exclusions are a leadless pacemaker, a device battery at "elective replacement indicator," or renal insufficiency (GFR \<45 cc/min).