Monitoring Subjects With Fluid-Management Issues In the Home Environment

Study Overview
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Brief Summary
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This study is designed to validate ease-of-use for the CoVa Monitoring System, along with simple statistical parameters such as reproducibility and inter-subject agreement between test and reference devices.

Detailed Description
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The study has the following objectives: Objective 1: investigate ease-of-use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational Objective 2: determine if daily application of the Sensor's adhesive Electrodes resulted in any skin irritation Objective 3: determine that the long-term reproducibility of measurements made by the test device is as good or better than the long-term reproducibility of the reference device

Official Title
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A Study for Monitoring Subjects With Fluid-Management Issues Using Repeated Measurements In the Home Environment

Conditions
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Heart Failure, Hypertension

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening. Subject will have a current prescription for a diuretic medication. Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study. Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition. Exclusion Criteria: Subject is participating in another clinical study that may affect the results of either study. Subject is unable or not willing to wear electrode patches as required. Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches. Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device. Subject is considered by the PI to be medically unsuitable for study participation.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Subjects taking diuretic medication<br>All subjects will be in the same group, Cohort 1 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of Use | Investigate ease of use associated with the CoVa Monitoring System: determine if subjects could use the test device on a daily basis, and if the components of this system (Sensor, Gateway, Web-based System) were indeed operational | Each subject will be measured once per weekday over a 6 week period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SKin irritation and reproducibility | Determine if subjects had skin irritation from daily use for 30 days. Determine the long-term reproducibility of the measurements from the test device versus the reference device | Each subject will be measured once per weekday over a 6 week period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Impedance, Fluids