Medtronic Inc., of Minneapolis, recently announced it has started a clinical trial to evaluate its Medtronic EnRhythm MRI SureScan pacing system, the first-ever pacemaker system to be developed and tested specifically for safe use in magnetic resonance machines under specified scanning conditions.
Designed to test the safety and efficacy of the pacing system, the trial is a prospective, randomized, controlled, unblinded, multi-center study that will involve 470 participants. Eligibility is based on the clinical indication for pacemaker implantation and a willingness and ability to undergo elective MR scanning.
All patients in the trial will receive an EnRhythm MRI SureScan pacing system, and two-thirds of the participants will undergo MR scans, which will take place approximately two to three months after device implant. The study will compare the electrical system performance among patients in both groups, as well as assess the MR-related complication rates in the month following scans.
The study is expected to last 30 months.
The EnRhythm MRI SureScan pacing system consists of the dual-chamber EnRhythm MRI SureScan pacemaker and CapSureFix MRI SureScan pacing leads.