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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02275923




Registration number
NCT02275923
Ethics application status
Date submitted
17/10/2014
Date registered
27/10/2014
Date last updated
5/04/2019

Titles & IDs
Public title
Reveal LINQ™ Evaluation of Fluid
Scientific title
Reveal LINQ™ Evaluation of Fluid
Secondary ID [1] 0 0
REEF
Universal Trial Number (UTN)
Trial acronym
REEF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End Stage Renal Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Reveal LINQ™ Insertable Cardiac Monitor

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.


Treatment: Devices: Reveal LINQ™ Insertable Cardiac Monitor
Insertable cardiac monitor

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Fluid Volume Removed - The average fluid volume removal during the dialysis session over all patients.
Timepoint [1] 0 0
24 Days
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
24 days

Eligibility
Key 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
Minimum age
21 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02275923
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02275923