Reveal LINQ™ Evaluation of Fluid (REEF)

Medtronic

Status: Terminated

Conditions: End Stage Renal Disease

Treatments: Device: Reveal LINQ™ Insertable Cardiac Monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT02275923

REEF

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Diagnostic

Experimental 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.

Treatment:

Device: Reveal LINQ™ Insertable Cardiac Monitor