June 19, 20207 - An international clinical trial will test a unique pacemaker, the Medtronic EnRhythm MRI SureScan pacing system, for use in Magnetic Resonance Imaging (MRI) systems under specified scanning conditions.
The device consists of the new dual-chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads (Model 5086MRI). All 350 patients in the trial will receive an EnRhythm MRI SureScan pacing system, and approximately half of the participants will receive MRI scans. The first MRI scans will occur two to three months after device implant, and the study will compare the electrical and diagnostic system performance, as well as complication rates, among patients in both groups. The expected study duration is approximately 24 months.
The clinical trial, a prospective, randomized controlled, unblinded, multi-center study, will take place in hospitals in Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Switzerland, the United States and United Kingdom.
For more information: www.medtronic.com