INGENIO MRI/ FINELINE II ImageReadyTM pacing system data collection in patients undergoing Magnetic Resonance Imaging - INFINITE MRI

Boston Scientific Cooperation International0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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•Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law
•Patients already implanted with ImageReady* MR Conditional Pacing System, including INGENIO* MRI or ADVANTIO* MRI pulse generators with FINELINE* II Sterox endocardial lead(s), according to standard medical guidelines for pacemaker implantation.
•Willing and capable of participation to the procedures indicated in the protocol.

•Patients implanted with pulse generator location outside of left or right pectoral regions
•Patients implanted with other cardiac-related implanted devices or accessories other than the ImageReadyTM MR Conditional Pacing System
•abandoned leads or pulse generators (PG)
•evidence of a fractured lead or compromised PG-lead system integrity
•Low life expectancy (< 1 year)
•Severe comorbidities that, according to clinical judgment, pose patient at risk to undergo MRI
•Women of childbearing potential who are or might be pregnant at the time of study enrollment or ImageReady MR Conditional Pacing System implant (method of assessment upon physician*s discretion)

发起方

Boston Scientific Cooperation International