Back to resultsReveal LINQ™ Evaluation of Fluid (REEF)
Primary Purpose
End Stage Renal Disease
Status
Terminated
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Reveal LINQ™ Insertable Cardiac Monitor
Sponsored by
About this trial
This is an interventional diagnostic trial for End Stage Renal Disease
Eligibility Criteria
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
Sites / Locations
- The Alfred Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic
Arm Description
'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.
Outcomes
Primary Outcome Measures
Average Fluid Volume Removed
The average fluid volume removal during the dialysis session over all patients.
Change in Subcutaneous Impedance
The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions
Secondary Outcome Measures
Full Information
NCT ID
NCT02275923
First Posted
October 17, 2014
Last Updated
April 3, 2019
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
1. Study Identification
Unique Protocol Identification Number
NCT02275923
Brief Title
Reveal LINQ™ Evaluation of Fluid
Acronym
REEF
Official Title
Reveal LINQ™ Evaluation of Fluid
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Study terminated as sufficient data was collected to determine if impedance measurements with the LINQ™ device could track body fluid changes.
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Cardiac Rhythm and Heart Failure
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic
Arm Type
Experimental
Arm Description
'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.
Intervention Type
Device
Intervention Name(s)
Reveal LINQ™ Insertable Cardiac Monitor
Intervention Description
Insertable cardiac monitor
Primary Outcome Measure Information:
Title
Average Fluid Volume Removed
Description
The average fluid volume removal during the dialysis session over all patients.
Time Frame
24 Days
Title
Change in Subcutaneous Impedance
Description
The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions
Time Frame
24 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
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Reveal LINQ™ Evaluation of Fluid
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