At a glance
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SMDC CRM-MRI Prospective Case Series
In Brief
An observational study evaluating MRI Scan for Arrhythmias, Cardiac. Completed, enrolled 124 participants across 1 site.
Detailed Summary
This study is a prospective, non-randomized, unblinded case series of patients with permanent pacemakers and implantable cardioverter-defibrillators undergoing medically-required magnetic resonance imaging (MRI) scanning, at St. Mary's Medical Center, Essentia Health. Patients will be enrolled over a 60-month period and followed for 12 months, with data collected to evaluate the study's primary endpoint, change in pacing thresholds over time, as well as a series of secondary endpoints, including: adverse events, symptoms, need to make pacemaker programming changes, and possible artifacts created by the pacemaker systems on the MRI scans. This study will allow for carefully monitoring of the safety MRI scanning in this population and improve practice models and protocols in the future.
Study Details
Timeline
Interventions
Clinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ.