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

Medtronic

Status

Completed

Conditions

End Stage Renal Disease

Treatments

Device: REVEAL Insertable Cardiac Monitor (ICM)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01779856

G120171

Details and patient eligibility

About

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.

Enrollment

81 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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