Status:
TERMINATED
Reveal LINQ™ Evaluation of Fluid
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
21+ years
Phase:
NA
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 hemodial...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02275923
Start Date
October 1 2014
End Date
July 1 2015
Last Update
April 5 2019
Active Locations (1)
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1
The Alfred Hospital
Melbourne, Victoria, Australia, 3004