Reveal LINQ™ Evaluation of Fluid (REEF)

• ClinicalTrials.gov Identifier: NCT02275923
• Recruitment Status: Terminated
• First Posted: October 27, 2014
• Results First Posted: April 5, 2019
• Last Update Posted: April 5, 2019
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Information provided by (Responsible Party): Medtronic Cardiac Rhythm and Heart Failure

Tracking Information

• First Submitted Date: October 17, 2014
• First Posted Date: October 27, 2014
• Results First Submitted Date: December 18, 2015
• Results First Posted Date: April 5, 2019
• Last Update Posted Date: April 5, 2019
• Study Start Date: October 2014
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 3, 2019)

• 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

Original Primary Outcome Measures (submitted: October 23, 2014)

• Slope of the regression line between fluid volume and subcutaneous impedance [ Time Frame: 24 Days ]

The linear association between fluid volume removal during the dialysis and change in subcutaneous impedance for dialysis sessions occurring from day 7 to day 30 after implant.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reveal LINQ™ Evaluation of Fluid
• Official Title: Reveal LINQ™ Evaluation of Fluid
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• 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

Insertable cardiac monitor

Study Arms

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.

Intervention: Device: Reveal LINQ™ Insertable Cardiac Monitor

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 3, 2019): 9
• Original Estimated Enrollment (submitted: October 23, 2014): 70
• Actual Study Completion Date: July 2015
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT02275923
• Other Study ID Numbers: REEF
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
• Original Responsible Party: Same as current
• Current Study Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medtronic Cardiac Rhythm and Heart Failure
• Verification Date: April 2019