Monitoring in Dialysis study

Not Applicable

Completed

• Conditions: Health Condition 1: null- Patients on hemodialysis atleast thrice-weekly,subjects with glomerular filtration rate less than (eGFR)15mL/min/1.73m2 who will begin hemodialysis within two months of the Reveal® XT implant.

• Registration Number: CTRI/2013/10/004057
• Lead Sponsor: India Medtronic Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified