Vivio At-Home Study

Enrolling by invitation · Not applicable

Conditions studied: Heart Failure

In brief

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 facts

Study ID

NCT07730268

Run by

Ventric Health, LLC

People needed

500

Starts

2025-10-20

Expected to finish

2029-12-31

Last updated by the study team

2026-07-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult subjects over the age of 21.
• A CardioMEMS HF System implanted or scheduled to be implanted.
• 70% or more signal strength from CardioMEMS at the time of enrollment.
• Ability to successfully obtain a Vivio System measurement.
• Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records up to 2 years after completion of the study.
• Ability to understand and sign informed consent.

You may not qualify if…

• Open skin lesions at the site of Vivio application / examination.
• Inability to obtain brachial artery blood pressure.

Where it is running

• 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

Full record on ClinicalTrials.gov

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