Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.

Monitoring in Dialysis

The primary objective of this study is to estimate the proportion of hemodialysis patients experiencing clinically significant cardiac arrhythmias over a 6-month period using continuous cardiac monitoring with an implanted Medtronic Reveal Insertable Cardiac Monitor (ICM) device.

Inclusion Criteria:

• 21 years of age or older and is willing to be implanted with the Reveal ICM
• Currently on hemodialysis at least three times per week OR has an estimated glomerular filtration rate (eGFR) of < 15 mL/min/1.73m^2 and is expected to begin hemodialysis within 2 months.
• Subject is willing and able to comply with the protocol

Exclusion Criteria:

• Currently enrolled in an interventional study that may interfere with the Monitoring in Dialysis protocol
• Not suitable for Reveal ICM implantation
• Has an existing hemodialysis catheter that may interfere with the Reveal ICM implantation site
• Has a recent infection
• Is currently on hemodialysis with a hemoglobin < 10 g/dL
• Has end-stage liver failure or has had thoracic surgery within the past 6 months
• Has an existing pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac resynchronization device
• Is scheduled for renal transplantation or will likely be transplanted within 6 months
• Is currently on home hemodialysis