It is currently difficult to perform MRIs on patients with pacemakers or defibrillators. Clinically, this is problematic for patients that need to have MRIs performed in order to determine if they have brain or spine injuries, but also have a pacemaker or defibrillator. The purpose of the MagnaSafe registry and study is to determine the risks of MRI in the presence of pacemakers and Implantable Cardio Defibrillators, and create a multi-center registry designed to prospectively document the safety of MRI performed on patients with pacemakers or ICDs.

The MagnaSafe Registry is a prospective multi-center study designed to determine the safety of non-thoracic 1.5T MRI scanning for patients with implanted cardiac devices. Patients with pacemakers or ICDs scheduled for a clinically-indicated MRI will be invited to enroll in the study. In this protocol, the decision to have an MRI will be based on the clinical need as determined by the patient’s ordering physician. Candidates must have a strong clinical indication for the scan, where MRI is the diagnostic modality of choice for a specific disease state without acceptable alternative imaging technology as judged by the ordering physician.

The protocol requires the participation of a cardiologist with a working knowledge of pacemaker and ICD function who is capable of device interrogation and programming (with the assistance of an industry device representative). Patients will have their device interrogated immediately before the scan, and the device will be reprogrammed appropriately. The patient will remain on a cardiac monitor with a physician present throughout the scan. Immediately following the MRI, the device will be re-interrogated and initial parameters restored. The incidence of adverse events or changes in device parameters between pre- and post-MRI interrogations and follow-up interrogations will be recorded. Reimbursement will be provided for the physician participation during the MRI procedure and completing follow-up device interrogations.

The protocol is performed as an investigator-initiated study with multiple sources of funding (competitive grants, foundation fellowship support, industry grants and philanthropy). The results of this registry may be used to establish guidelines for the use of clinically-indicated, non-thoracic MRI for patients with implanted cardiac devices.

The study will be a multi-center, prospective registry of patients with implanted cardiac devices who undergo MRI for clinical purposes. Incidence of device parameter changes or adverse events will be recorded, with a cardiologist present to monitor the patient. In terms of scope, the study will take place at up to 35 sites and involve 1500 subjects (1000 with pacemakers and 500 with ICDs). The Lead Principle Investigator at the Scripps Clinic will be Brain Carlos, MD, Division of Cardiology. Kevin Yoo, M.D. and Gail Tominaga, M.D. are coinvestigators.

For contact information an inclusion/exclusion criteria, please take a look at this study summary.