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Vivio At-Home Study
Sponsor: Ventric Health, LLC
Summary
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
Official title: Evaluation of a Novel, Non-Invasive Approach to Estimating Pulmonary Artery Pressure as an Alternative Method for Tracking Heart Failure Status
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-10-20
Completion Date
2029-12-31
Last Updated
2026-07-28
Healthy Volunteers
No
Conditions
Interventions
Vivio measurement
The Vivio measurement is taken after a CardioMEMS measurement
Locations (4)
MemorialCare Long Beach Medical Center
Long Beach, California, United States
USC Keck School of Medicine
Los Angeles, California, United States
UC San Diego School of Medicine
San Diego, California, United States
Renown Regional Medical Center
Reno, Nevada, United States