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.

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

sites

Clinical Trial Facility in Boston Massachusetts

Boston, Massachusetts

from

Boston, MA