Health Condition 1: null- Patients on hemodialysis at least thrice-weekly,subjects with glomerular filtration rate less than (eGFR)15 mL/min/1.73m2 who will begin hemodialysis within two months of the Reveal® XT implant.
Conditions
Interventions
Intervention1: Reveal XT Insertable Cardiac Monitor and Reveal LINQTM Implantable ICM: The Medtronic Reveal XT Model 9529 is
a leadless, implantable, battery-powered, magnetic resonance (MR)
condition
Sponsors
India Medtronic Pvt Ltd
Eligibility
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to estimate the proportion of hemodialysis subjects experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted Medtronic Reveal® ICM device.Timepoint: within 6 months after first dialysis session post device- implant | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the rate of device and procedure related adverse events (AEs) associated with the use of the Reveal® XT in ESRD patients. 2) To document the nature and timing of health-related events (such as hospitalization, hyper or hypovolemia, worsening heart failure, sudden cardiac death, etc.) and treatment associated with ESRD and other conditions occurring in the implanted patients.Timepoint: As mentioned above | — |
Countries
India
Contacts
Public ContactRajesh Radhakrishnan
India Medtronic Pvt. Ltd.
Outcome results
None listed