An observational study in Arrhythmias, Cardiac, sponsored by University of Arizona. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Arizona · Observational
The research goal is to continue to add to the extensive body of peer-reviewed evidence that demonstrates MRI may be safely performed in patients with cIEDs, after they have been evaluated and cleared by cardiology. This study will allow the researchers to collect data from the facilities ongoing clinical practice regarding the number and types of any adverse clinical reactions, and also to document any changes in the implanted cardiac device that may have occurred during the MRI scan. The researchers will also be assessing the results of the MRI and how the imaging findings impact patient care and the clinical outcome of the patient. This data will then be presented to the FDA and the Centers for Medicare and Medicaid Services to further influence federal guidelines and payment structures.
Cardiac implantable electronic devices (cIEDs) generally refer to implanted pacemakers and defibrillators for patients with cardiac disorders affecting their heart rhythm. Previously, cIEDs have been regarded as a contraindication to magnetic resonance imaging (MRI) scans, with concerns that the magnetic fields of the MRI may cause problems with the patient's cIED. However, this is a major healthcare issue, as approximately 50-75% of patients with implanted cIEDs are expected to need a future MRI as part of their clinical care. The inability to get such a test may negatively impact the ability to diagnose and treat future diseases.
However, many of the initial concerns regarding the capability of performing MRI in patients with cIED have likely been overstated. There is peer-reviewed literature dating back to the 1990s regarding the ability to safely perform MRI in patients with cIEDs, if certain protocols are followed regarding patient selection and monitoring. In 2011, Nazarian et al from Johns Hopkins University published a study on 438 patients with cIED that received MRI. There were no adverse clinical effects from this study. In fact, the American College of Radiology updated it's guidance document for Safe MR Practices, and cIEDs are no longer listed as a relative contraindication to obtaining an MRI. However, the presence of cIEDs are still regarded as a relative contraindication to performing MRI at some centers. In addition, performance of MRI in the setting of cIED is denied by the Centers for Medicare and Medicaid Services. Continued accrual of data regarding the safety of performing MRI in patients with cIEDs is needed, including outcomes studies that document the clinical impact of improved diagnostics provided by the MRI on patient care.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
Browse Arrhythmias, Cardiac studies →University of Arizona is the lead sponsor of 466 studies on the registry; 87 are open to participants now.
Of its 47 completed or terminated interventional studies of FDA-regulated products, 29 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients that require an MRI as part of the normal course of their medical care that also have a cIED and are candidates for MRI .
Exclusion Criteria:
Safety of MRI, adverse clinical events
collect safety data
Time frame: immediately post MRI
Impact to Patient Care
assess the results of the MRI and how the imaging findings impact patient care
Time frame: 6 months
Morbidity, Number of hospitalizations
collected from medical record
Time frame: 6 months
Mortality, outcome of death
collected from medical records and phone calls
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Arizona