INGENIO 2 /INGEVITY MRI device family data collection in patients undergoing Magnetic Resonance Imaging - INFINITE 2 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23日

适应症

试验速览

暂无简介。

•* 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 2* MRI pulse generators with INGEVITY MRI 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