Patients with implanted cardiac devices who meet appropriate entrance criteria undergo clinically indicated Magnetic Resonance (MR) Imaging Studies using an established safety protocol.
This prospective cohort study to use an established MRI device safety protocol to decrease the risk of clinically indicated MR imaging in patients with implantable cardiac devices. All devices will undergo a complete interrogation and testing of thresholds, sensing, battery voltage and impedances prior to and following imaging. Pre-MRI, devices will be programmed to setting that will ensure MRI safety. During imaging, patients will blood pressure, heart rate and O2 sat level will be monitored continuously.
Study Type
OBSERVATIONAL
Enrollment
1,509
Johns Hopkins Hospital, Blalcok 5 MRI
Baltimore, Maryland, United States
Device Malfunction
Number of patients with change in device testing defined as a change in any of the following (impedance, battery life, p and r wave sensing and atrial and ventricular capture thresholds) not to exceed 50 percent from baseline
Time frame: immediately post MRI (up to 2 hours) and long-term follow-up (up to 6 months)
Patient Safety
Number of patients with change in vital signs including blood pressure, heart rate and pulse oximetry not to exceed 10 percent from baseline lead impedances as well as patient reports of any discomfort related to MRI)
Time frame: assessed during MRI and immediate post MRI (up to 2 hours)
Noise Artifacts as Assessed by the Number of Participants With a Greater Than a 50% Change in Lead Impedance
We will evaluate whether or not the artifacts produced are significant enough to prevent diagnostic interpretation of images
Time frame: Immediately post MRI (up to 2 hours)
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