Vivio At-Home Study

Part of paid clinical trials in Long Beach, California.

Sponsor
Ventric Health, LLC
Study ID
NCT07730268
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vivio measurement — DIAGNOSTIC_TEST
    The Vivio measurement is taken after a CardioMEMS measurement

Study Details

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

Key Dates

First listed
Jul 28, 2026
Start date
Oct 20, 2025
Status verified
Jul 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Vivio comparison to CardioMEMS
    Observational comparison of Vivio measurements to CardioMEMS measurements

Primary Outcome Measure

Comparing Vivio measurements to CardioMEMS measurements over time [ Time Frame: From enrollment to the end of participation at 30-90 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
MemorialCare Long Beach Medical CenterLong BeachCalifornia90806-
USC Keck School of MedicineLos AngelesCalifornia90033-
UC San Diego School of MedicineSan DiegoCalifornia92037-
Renown Regional Medical CenterRenoNevada89502-

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