Reveal LINQ™ Evaluation of Fluid (REEF)

April 3, 2019 updated by: Medtronic Cardiac Rhythm and Heart Failure
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: Reveal LINQ™ Insertable Cardiac Monitor
Insertable cardiac monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Fluid Volume Removed
Time Frame: 24 Days
The average fluid volume removal during the dialysis session over all patients.
24 Days
Change in Subcutaneous Impedance
Time Frame: 24 days
The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions
24 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (ACTUAL)

July 1, 2015

Study Completion (ACTUAL)

July 1, 2015

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (ESTIMATE)

October 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 3, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REEF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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