Monitoring in Dialysis Clinical Study India - MID Study

India Medtronic Pvt Ltd0 个研究点目标入组 100 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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•Subject is 21 years of age or older
•Subject is willing to be implanted with the RevealÂ® ICM
•Subject has been diagnosed with ESRD and on hemodialysis at least three times per week
•OR has an estimated glomerular filtration rate (eGFR) of < 15 mL/min/1.73m2 and is
•expected to begin hemodialysis within 2 months of the RevealÂ® ICM implant, in the
•opinion of the investigator
•Subject is willing and able to comply with the protocol, including sending data to the
•Medtronic CareLinkÂ® Network using a CareLinkÂ® Monitor as requested

•Subject is currently enrolled in an interventional study that may interfere with the
•Monitoring in Dialysis protocol. Enrollment into another observational study is permitted
•Subject not suitable for RevealÂ® ICM implantation (e.g., severe cachexia, dermatologic
•conditions of the skin, or major medical or social conditions expected to reduce survival to
•6 months), in the opinion of the investigator
•Subject with an existing hemodialysis catheter that exits the left chest wall below the
•clavicle and may interfere with the RevealÂ® ICM implantation site, in the opinion of the
•investigator
•Subject with a recent infection defined as 1) bacteremia within 60 days OR 2) (nonbacteremic)
•infection within 14 days
•Subject has end-stage liver failure, as determined by the investigator
•Subject has had thoracic surgery within the past 6 months
•Subject has an existing pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac
•resynchronization devices
•Subject who is scheduled for renal transplantation or will likely be transplanted within 6 months, in the opinion of the investigator
•Subject that is currently on home hemodialysis, is scheduled to transition to home
•hemodialysis or to peritoneal dialysis within 6 months, in the opinion of the investigator

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