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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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REVEAL Insertable Cardiac Monitor (ICM)

Monitoring of cardiac arrhythmic events and the relationship between such events and the characteristics.

Group Type OTHER

REVEAL Insertable Cardiac Monitor (ICM)

Intervention Type DEVICE

Interventions

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REVEAL Insertable Cardiac Monitor (ICM)

Intervention Type DEVICE

Other Intervention Names

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Reveal ICM

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No