A clinical evaluation of the SJM MRI Conditional Pacing System in subjects undergoing Cardiac Magnetic Resonance Imaging (MRI) - Accent Cardiac MRI study

St Jude Medical India Pvt Ltd0 个研究点目标入组 252 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Have an approved indication per ACC/AHA/HRS/ESC guidelines for implantation of a pacemaker
•Will receive a new dual chamber pacemaker and leads
•Be willing to undergo an elective MRI scan without complete sedation, that is ,under
•consciousness during MRI scan
•Be able to provide informed consent for study participation
•Be willing and able to comply with the prescribed follow-up tests and schedule of evaluations
•Is not contraindicated for an MRI scan (per the pre-MRI safety screening form)
•Age greater than equal to 18 years
•Subjects must be able to undergo pectoral implantation

•Having an existing pacemaker or ICD .A new pacemaker and lead is required for
•Permanent Atrial Fibrillation/Flutter
•Are medically indicated for an MRI scan at the time of enrollment
•Have an existing active implanted medical device, e.g. neurostimulator, infusion pump etc
•Have a non-MRI compatible device or material implanted
•Have a lead extender or adaptor
•Be unable to fit in MRI bore; will come into contact with the magnet faÃ§ade inside the
•Are currently participating in a clinical investigation that includes an active treatment
•Are allergic to dexamethasone sodium phosphate(DSP)
•Are pregnant or planning to become pregnant during the duration of the study
•Have a life expectancy of less than 12 months due to any condition
•Subjects with exclusion criteria required by local law (e.g.age)
•Are unable to comply with the follow up schedule

发起方

St Jude Medical India Pvt Ltd