The cumulative effects and clinical safety of repeat magnetic resonance imaging on an MRI-conditional Pacemaker system at 1 .5 Tesla
نویسندگان
چکیده
Methods The ProMRI study, a multicenter prospective trial of an MRI conditional pacemaker (PM), was approved by local institutional review boards (IRB) and all patients provided written informed consent. Patients underwent head and lumbar and cardiac or thoracic MRIs under 1.5-T conditions and five underwent additional clinical MRI exams. Discrete PM parameters, including chamber pacing capture threshold (PCT), lead impedance (LI), sensing amplitude (SA), and battery capacity (BC) were collected before phase A and immediately and 3 months post phase B. Freedom from pacing system-related serious adverse device effects (SADEs) through 1 month post-MRI served as a primary end-point. Mean changes in pacemaker function parameters, as well as threshold successes and freedom from attenuation, were analyzed for clinical relevance and statistical significance using paired t-tests, serving as additional endpoints.
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