Vivio At-Home Study for Heart Failure

This study is looking at how well a new system, called Vivio, can track heart failure. Heart failure is a condition where your heart doesn't pump enough blood. Researchers want to compare Vivio measurements to those from the CardioMEMS system, which is already used to monitor heart failure. You might be able to join if you are over 21, have a CardioMEMS device implanted or are scheduled to get one, and can successfully use the Vivio System. The main goal is to see if Vivio measurements match CardioMEMS measurements over 30 to 90 days. The study's status is currently unclear.

Study design
This study is a comparative study involving up to 500 participants across the United States.
What's involved
You would take Vivio and CardioMEMS measurements 2-4 times per week for 30 to 90 days. You will also have a blood draw, complete questionnaires, and be trained on using Vivio.
Compensation
Not stated in the trial record.
Follow-up
Measurements will be taken from enrollment to the end of participation at 30-90 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07730268

Vivio At-Home Study

Enrolling by Invitation
NAAges 21+InterventionalDiagnostic
Ventric Health, LLC
~500 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:Vivio measurement

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparing Vivio measurements to CardioMEMS measurements over time
Measured over From enrollment to the end of participation at 30-90 days
Heart Failure
4 sites across 2 states
California3
Nevada1

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Open skin lesions at the site of Vivio application / examination.
Inability to obtain brachial artery blood pressure.
  • Comparing Vivio measurements to CardioMEMS measurements over timeFrom enrollment to the end of participation at 30-90 days

    To assess the longitudinal agreement between non-invasive hemodynamic signals collected using the Vivio System and pulmonary artery pressure (PAP) measurements obtained via the CardioMEMS HF System.