The MagnaSafe Registry is a prospective multi-center study designed to determine the risks of performing non-thoracic 1.5T MRI scanning for patients with implanted pacemakers and Implantable Cardioverter-Defibrillators (ICDs).We will determine the rates of temporary and permanent device parameter changes, including changes in lead threshold, lead impedance and battery voltage. It is anticipated that the results of the registry will change the published guidelines for performing MRI in patients with implanted cardiac devices and provide physicians the risk-assessment data needed to assess the use of MRI as a diagnostic tool when no alternative diagnostic imaging technology is appropriate.
Patients with pacemakers or ICDs scheduled for a clinically-indicated MRI will be invited to enroll in the study.The MRI procedures will be conducted for clinical purposes at the discretion of the ordering physician.MR examination of patients with permanent implanted cardiac devices will only be performed if there are highly compelling circumstances and when the benefits clearly outweigh the risks in the opinion of the ordering physician. The decision to have an MRI must be based on clinical indication, and is not part of the research protocol.
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 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).
This is an investigator-initiated study that will be coordinated by Scripps Clinic, Torrey Pines.Funding for the MagnaSafe Registry comes from multiple sources including competitive grants, institutional grants, foundation fellowship support, unrestricted educational grants from industry, and philanthropy.
We have obtained an investigator-initiated investigational device exemption (IDE) from the FDA to conduct the registry. The registry uses a protocol designed to minimize potential risk to the patient and device.