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A patch, not a surgery: new device aims to monitor heart failure without implants

NCT ID NCT07730268

Diagnosis Sponsor: Ventric Health, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This study tests whether a non-invasive device called Vivio can accurately track heart failure status by measuring blood pressure in the lungs. Researchers will compare Vivio readings to those from an implanted CardioMEMS sensor in 500 adults over age 21 who already have or will receive the implant. The goal is to see if the Vivio system can serve as a simpler, safer alternative for monitoring heart failure over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Vivio System (non-invasive hemodynamic monitoring device)
What this could lead to
If successful, this could offer a needle-free, implant-free way to monitor heart failure at home, potentially reducing hospital visits.
What could go wrong
This is an early-stage comparison study, not a treatment trial. The Vivio device may not match the accuracy of the implanted CardioMEMS, and results may not change current care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * Open skin lesions at the site of Vivio application / examination. * Inability to obtain brachial artery blood pressure.

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Conditions

The condition(s) this trial relates to.

disease heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MemorialCare Long Beach Medical Center

    Long Beach, California, 90806, United States

  • Renown Regional Medical Center

    Reno, Nevada, 89502, United States

  • UC San Diego School of Medicine

    San Diego, California, 92037, United States

  • USC Keck School of Medicine

    Los Angeles, California, 90033, United States

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