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Reveal LINQ™ Evaluation of Fluid (REEF)

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ClinicalTrials.gov Identifier: NCT02275923
Recruitment Status : Terminated (Study terminated as sufficient data was collected to determine if impedance measurements with the LINQ™ device could track body fluid changes.)
First Posted : October 27, 2014
Results First Posted : April 5, 2019
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition End Stage Renal Disease
Intervention Device: Reveal LINQ™ Insertable Cardiac Monitor
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Diagnostic
Hide Arm/Group 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.

Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor
Period Title: Overall Study
Started 9
Completed 7
Not Completed 2
Arm/Group Title Diagnostic
Hide Arm/Group 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.

Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  71.4%
>=65 years
2
  28.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
53.3  (19.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
0
   0.0%
Male
7
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 7 participants
7
1.Primary Outcome
Title Average Fluid Volume Removed
Hide Description The average fluid volume removal during the dialysis session over all patients.
Time Frame 24 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Diagnostic
Hide Arm/Group 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.

Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: mL
2948  (683)
2.Primary Outcome
Title Change in Subcutaneous Impedance
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients implanted with a LINQ having at least one dialysis session between 7 and 30 days post-implant
Arm/Group Title Diagnostic
Hide Arm/Group 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.

Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: ohm
207  (97)
Time Frame Subjects were followed on average of 4.7 months with a range of 3 to 6 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diagnostic
Hide Arm/Group 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.

Reveal LINQ™ Insertable Cardiac Monitor: Insertable cardiac monitor
All-Cause Mortality
Diagnostic
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Diagnostic
Affected / at Risk (%) # Events
Total   1/7 (14.29%)    
Eye disorders   
Conjunctivitis [1]  1/7 (14.29%)  1
Gastrointestinal disorders   
Intestinal ischaemia [2]  1/7 (14.29%)  1
Renal and urinary disorders   
Arteriovenous fistula [3]  1/7 (14.29%)  1
[1]
Patient presented to the Alfred Hospital with headache, fever and photophobia. Following admission and assessment he was diagnosed with conjunctivitis and discharged on the 28th July.
[2]
Patient presented to Emergency with worsening abdominal pain. A abdominal CT scan showed ischemic bowel and an evolving small bowel obstruction. The subject underwent a laparotomy and small bowel resection.
[3]
Post dialysis on the 20.01.15, a thrombosed AVF was diagnosed post ultrasound and was admitted to the Alfred Hospital for a planned fistulagram and plasty. He then required an extra dialysis session.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Diagnostic
Affected / at Risk (%) # Events
Total   1/7 (14.29%)    
Surgical and medical procedures   
Application site anaesthesia [1]  1/7 (14.29%)  1
[1]
Pt has complained of mild numbness and very occasional discomfort at the implant site since 11.04.15. R/w by Dr Scott Wilson and nil signs of infection or cause for concern. Patient happy to continue.
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jennifer Seamans, Principal Clinical Research Specialist
Organization: Medtronic
Phone: 7635262835
EMail: jennifer.l.seamans@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT02275923    
Other Study ID Numbers: REEF
First Submitted: October 17, 2014
First Posted: October 27, 2014
Results First Submitted: December 18, 2015
Results First Posted: April 5, 2019
Last Update Posted: April 5, 2019