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ENROLLING BY INVITATION
NCT07730268
NA

Vivio At-Home Study

Sponsor: Ventric Health, LLC

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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