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Investigating the BrioVAD System for Advanced Heart Failure

This study is looking at a new device called the BrioVAD System for people with advanced heart failure. Heart failure means your heart can't pump enough blood to meet your body's needs. The BrioVAD System is a type of Left Ventricular Assist Device (LVAD), which is a mechanical pump that helps your heart. Researchers want to see if the BrioVAD System is as safe and effective as the HeartMate 3, which is a standard treatment. You could be eligible if you are 18 to 100 years old and have severe heart failure that hasn't improved with other treatments. The study aims to enroll 780 participants. The current status of this study is unclear.

Study design
This is a randomized study comparing the BrioVAD System to the HeartMate 3 in about 780 participants. It is not blinded, meaning both you and your doctors will know which device you receive.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 24 months to assess the long-term effects of the devices.

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

NCT06310031

Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure

Recruiting
NAAges 18+InterventionalTreatment
BrioHealth Solutions, Inc.
~780 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:BrioVAD SystemHeartMate 3

At a glance

Recruiting sites
47 of 47 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Short-Term Indication Primary Endpoint
Measured over 6 months
+1 more outcome measured

Conditions

Cardiovascular Diseases
Heart Diseases
Heart Failure

Explore related trials

Heart Failure

NCT06310031

Where you'd take part

This study runs at 47 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Abbott Northwestern Hospital

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

  • Advent Health

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Advocate Christ Medical Center

    Chicago, Illinoisstudy coordinator listed

    Recruiting

  • Ascension St. Vincent Hospital - Indianapolis

    Indianapolis, Indianastudy coordinator listed

    Recruiting

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsinstudy coordinator listed

    Recruiting

  • Baptist - Memphis (Stern)

    Memphis, Tennesseestudy coordinator listed

    Recruiting

  • Baptist Health Medical Center-Little Rock

    Little Rock, Arkansasstudy coordinator listed

    Recruiting

  • Baylor Scott & White Medical Center - Plano

    Plano, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Pranesh Thirukkonda
[email protected]
12014016539
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Short-Term Indication Primary Endpoint6 months

    Composite of survival to transplant, recovery or 6 months of LVAD support free of debilitating stroke \[modified Rankin Scale (mRS) \> 3\], or reoperation to replace the pump

  • Long-Term Indication Primary Endpoint24 months

    Composite of survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (mRS \> 3), or reoperation to replace the pump.