CTRI/2013/10/004057
Completed
未知
Monitoring in Dialysis Clinical Study India - MID Study
Overview
- Phase
- 未知
- Status
- Completed
- Sponsor
- India Medtronic Pvt Ltd
- Enrollment
- 100
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Subject is 21 years of age or older
- •Subject is willing to be implanted with the Reveal® 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 Reveal® ICM implant, in the
- •opinion of the investigator
- •Subject is willing and able to comply with the protocol, including sending data to the
- •Medtronic CareLink® Network using a CareLink® Monitor as requested
Exclusion Criteria
- •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 Reveal® 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 Reveal® 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
Investigators
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