Clinical trial NCT01779856: Monitoring in Dialysis -- a Prospective, Multi-center, Single-arm, Non-randomized, Observational Study in Patients Who Are Undergoing Hemodialysis.
Official title: Monitoring in Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease, Hemodialysis, Arrhythmia, Reveal ICM
Lead sponsor: Medtronic Corporate Technologies and New Ventures
Sponsor class: INDUSTRY
First posted: 2013-01-30
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Clinically Significant Cardiac Arrhythmias Using Continuous Cardiac Monitoring Over a 6-month Period With an Implanted Medtronic Reveal ICM Device
timeFrame: 6 months of dialysis data following Reveal ICM implant
Secondary outcomes:
measure: Collect the Number of Device and Procedure Related Adverse Events (AEs).
timeFrame: 6 months of dialysis data following Reveal ICM implant
measure: Nature and Time of Health-related Events and Treatment Associated With ESRD and Other Conditions Occurring in the Implanted Patients
timeFrame: up to 6 months and through study completion
measure: Rate of Arrhythmias by Intradialytic Potassium Change and Volume Removed
timeFrame: 6 Month Follow-up
measure: Collect and Quantify the Episodes of Arrhythmias
timeFrame: 6 months of dialysis data following Reveal ICM implant
measure: Assess Whether the Morphology of ECG Recordings Captured by the Reveal ICM Device Correlate With Serum Electrolyte Levels Measured Just Before and Just After Dialysis Sessions.
timeFrame: 6 months
Other outcomes:
Locations:
city: Augusta
country: United States
state: Georgia
city: Boston
country: United States
state: Massachusetts
city: Cincinnati
country: United States
state: Ohio
city: Chattanooga
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Chennai
country: India
city: Gurgaon
country: India
city: Hyderabad
country: India
city: New Delhi
country: India
city: New Delhi
country: India
Study officials:
References:
citation: Tumlin JA, Roy-Chaudhury P, Koplan BA, Costea AI, Kher V, Williamson D, Pokhariyal S, Charytan DM; MiD investigators and Committees. Relationship between dialytic parameters and reviewer confirmed arrhythmias in hemodialysis patients in the monitoring in dialysis study. BMC Nephrol. 2019 Mar 5;20(1):80. doi: 10.1186/s12882-019-1212-6.