Reveal LINQ™ Evaluation of Fluid

End Stage Renal Disease Clinical Trial

— REEF  

Official title:

Reveal LINQ™ Evaluation of Fluid

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02275923
• Other study ID #: REEF
• Status: Terminated
• Phase: N/A
• Start date: October 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2019
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Reveal LINQ™ Insertable Cardiac Monitor
Insertable cardiac monitor

Locations

Country	Name	City	State
Australia	The Alfred Hospital	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Fluid Volume Removed	The average fluid volume removal during the dialysis session over all patients.	24 Days
Primary	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