Reveal LINQ™ Evaluation of Fluid

NCT02275923 | Terminated Results

• 1 other identifier: REEF
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease

Outcome Measures

Primary Outcomes (2)

• Average Fluid Volume Removed

  The average fluid volume removal during the dialysis session over all patients.

  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

  24 days

Study Arms (1)

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.

Device: Reveal LINQ™ Insertable Cardiac Monitor

Interventions

Reveal LINQ™ Insertable Cardiac Monitor DEVICE

Insertable cardiac monitor

Diagnostic

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (1)

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jennifer Seamans, Principal Clinical Research Specialist
• Organization: Medtronic

jennifer.l.seamans@medtronic.com

7635262835

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 5, 2019
• Results First Posted: April 5, 2019

Record last verified: 2019-04

Locations

AU (1)