NCT07730268Enrolling by invitation
Vivio At-Home Study
Evaluation of a Novel, Non-Invasive Approach to Estimating Pulmonary Artery Pressure as an Alternative Method for Tracking Heart Failure Status
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 20 Oct 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Ventric Health, LLC
- Diseases
- Heart failure
- NCT number
- NCT07730268
What you commit to
- Study type: Interventional
- Planned participants: 500
- From 20 Oct 2025 to the primary completion date, 31 Dec 2028
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Open skin lesions at the site of Vivio application / examination.
- Inability to obtain brachial artery blood pressure.
Who the study is looking for
- 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.
Age in the registry: 21 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MemorialCare Long Beach Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| USC Keck School of Medicine Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Renown Regional Medical Center Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| UC San Diego School of Medicine Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.