Study the Characteristics of Cardiac Related Events in Hemodialysis Patients
Status: | Completed |
---|---|
Conditions: | Renal Impairment / Chronic Kidney Disease |
Therapuetic Areas: | Nephrology / Urology |
Healthy: | No |
Age Range: | 21 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2013 |
End Date: | September 2015 |
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.
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
We found this trial at
6
sites
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