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Vivio System for Heart Failure

Enrolling by invitation at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ventric Health, LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to examine the Vivio System's ability to track heart failure status in subjects, and compare the Vivio System's measurements to CardioMEMS measurements. Heart failure, which is a form of heart disease, is a condition where the heart does not pump enough blood through the body, resulting in the body not getting the amount of oxygen and nutrients it needs. This research study will collect data using CardioMEMS and the Vivio System in subjects over the age of 21 with a currently implanted, or scheduled to be implanted, CardioMEMS device. This group of individuals will provide researchers with important data because the measurements of their health information can be used to determine if the Vivio is as effective at tracking heart failure status as CardioMEMS. This research study is designed to develop new knowledge, and does not provide a direct benefit to study subjects

Are You a Good Fit for This Trial?

This study is for adults over age 21 who have heart failure and already have, or are about to get, a CardioMEMS device implanted. Participants should be able to use the Vivio System at home.

Inclusion Criteria

Ability to successfully obtain a Vivio System measurement
70% or more signal strength from CardioMEMS at the time of enrollment
I am over 21 years old.
See 3 more

Exclusion Criteria

I have open sores where the Vivio device will be used.
Inability to obtain brachial artery blood pressure

What Are the Treatments Tested in This Trial?

Trial Overview

The trial is testing whether the Vivio System can accurately track heart failure status at home by comparing its measurements with those from an implanted CardioMEMS device. No new drugs or treatments are given.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Vivio comparison to CardioMEMSExperimental Treatment1 Intervention

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Who Is Running the Clinical Trial?

Ventric Health, LLC

Lead Sponsor

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