Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2014-10-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic
'Reveal LINQ™ Insertable Cardiac Monitor' will be used to measure changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions.
Reveal LINQ™ Insertable Cardiac Monitor
Insertable cardiac monitor
Interventions
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Reveal LINQ™ Insertable Cardiac Monitor
Insertable cardiac monitor
Eligibility Criteria
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Inclusion Criteria
* Patients willing to be implanted with the Reveal LINQ™ device
* Patients greater than 21 years of age
* Patients willing and able to comply with the study procedures including giving informed consent
Exclusion Criteria
* Patients who currently undergo home dialysis treatment
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager.
* Patient with a recent infection defined as 1) bacteremia within 60 days OR 2) (nonbacteremic) infection within 14 days
* Patient not suitable for Reveal LINQ™ implantation (e.g., severe cachexia, dermatologic conditions of the skin, or major medical or social conditions expected to reduce survival to \< 6 months), in the opinion of the investigator
21 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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The Alfred Hospital
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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REEF
Identifier Type: -
Identifier Source: org_study_id
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