Reveal LINQ™ Evaluation of Fluid

Not Applicable

Terminated

• Conditions: End Stage Renal Disease
• Interventions: Device: Reveal LINQ™ Insertable Cardiac Monitor

• Registration Number: NCT02275923
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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 available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-17
• Study First Submitted QC: 2014-10-23
• Study First Posted: 2014-10-27
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Results First Submitted: 2015-12-18
• Status Verified: 2019-04
• Results First Submitted QC: 2019-04-03
• Last Update Submitted: 2019-04-03
• Results First Posted: 2019-04-05
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic	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.

Primary Outcome Measures

Name	Time	Method
Change in Subcutaneous Impedance	24 days	The change in impedance from the beginning to the end of a dialysis session, averaged over all patients and dialysis sessions
Average Fluid Volume Removed	24 Days	The average fluid volume removal during the dialysis session over all patients.

Trial Locations

Locations (1)

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia