Reveal LINQ™ Evaluation of Fluid

NCT ID: NCT02275923

Last Updated: 2019-04-05

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

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-07-31

Brief Summary

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The purpose of this study is to investigate the use of subcutaneous impedance measured with an implanted Medtronic Reveal LINQ™ insertable cardiac monitor for use as a fluid status monitor in hemodialysis patients. The study will measure the changes in subject subcutaneous impedance and compare with the fluid status assessed by the volume removed from the hemodialysis subject during dialysis sessions. Subcutaneous impedance trends will also be evaluated between dialysis sessions.

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

DIAGNOSTIC

Blinding Strategy

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.

Group Type EXPERIMENTAL

Reveal LINQ™ Insertable Cardiac Monitor

Intervention Type DEVICE

Insertable cardiac monitor

Interventions

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Reveal LINQ™ Insertable Cardiac Monitor

Insertable cardiac monitor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who currently undergo in-clinic hemodialysis treatment prescribed 2 or 3 times per week
* 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

* Patient has an active implanted cardiac medical device (e.g. IPG, ICD, CRT, etc)
* 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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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REEF

Identifier Type: -

Identifier Source: org_study_id

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