End Stage Renal DiseaseREEFNCT02275923

Reveal LINQ™ Evaluation of Fluid

A study testing Reveal LINQ™ Insertable Cardiac Monitor in people with End Stage Renal Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: Reveal LINQ™ Insertable Cardiac Monitor
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteAustralia
Study dates: Oct 2014to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

The Alfred Hospital
Melbourne, Victoria, 3004

Other trials in Australia

About this study

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.

Conditions: End Stage Renal Disease
Being tested: Reveal LINQ™ Insertable Cardiac Monitor
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reveal LINQ™ Insertable Cardiac MonitorDevice
Insertable cardiac monitor

Study groups in NCT02275923
Study group	Role	What they receive
Diagnostic	Experimental	'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. Receives: Device: Reveal LINQ™ Insertable Cardiac Monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

Average Fluid Volume Removed
The average fluid volume removal during the dialysis session over all patients.
Measured: 24 Days
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
Measured: 24 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Jul 2015

First posted27 Oct 2014 (estimated)
Study startOct 2014
Primary completionJul 2015
Study completionJul 2015

Why it stopped: Study terminated as sufficient data was collected to determine if impedance measurements with the LINQ™ device could track body fluid changes.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02275923
Sponsor's protocol ID: REEF
Acronym: REEF
Status last verified: Apr 2019
First submitted: 17 Oct 2014
Last updated: 5 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reveal LINQ™ Evaluation of Fluid
ClinicalTrials.gov ID: NCT02275923
Acronym / sponsor ID: REEF / REEF
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated as sufficient data was collected to determine if impedance measurements with the LINQ™ device could track body fluid changes.
Enrolment: 9 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 27 Oct 2014 (estimated)
Results: Posted 5 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Diagnostic	Experimental	Device: Reveal LINQ™ Insertable Cardiac Monitor'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.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reveal LINQ™ Insertable Cardiac MonitorInsertable cardiac monitor	Device	Diagnostic

Primary outcome

Average Fluid Volume Removed
Time frame: 24 Days
The average fluid volume removal during the dialysis session over all patients.
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

Results and safety

Results posted to the registry on 5 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diagnostic	9	7

Primary outcome: Average Fluid Volume Removed

Time frame: 24 Days. Mean (Standard Deviation). Unit: mL

Measure	Diagnostic n = 6
Value	2948 (683)

Population analysed: Enrolled patients implanted with a LINQ device that had at least one dialysis session between 7 and 30 days post-implant. Formal statistical analysis was not performed because the likelihood from the pre-specified model did not converge due to small sample size. Average fluid loss is summarized instead.

Primary outcome: Change in Subcutaneous Impedance

Time frame: 24 days. Mean (Standard Deviation). Unit: ohm

Measure	Diagnostic n = 6
Value	207 (97)

Population analysed: Patients implanted with a LINQ having at least one dialysis session between 7 and 30 days post-implant

Adverse events

Time frame: Subjects were followed on average of 4.7 months with a range of 3 to 6 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diagnostic	1 of 7 (14.3%)	1 of 7 (14.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Reveal LINQ™ Insertable Cardiac Monitor in people with End Stage Renal Disease, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Fluid Volume Removed (time frame: 24 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02275923.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2019.