🏛️ Verified NIH Record • Updated 2026-08-14

Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure (NCT06310031)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: BrioHealth Solutions, Inc.

🩺 Plain-English Summary (8th-Grade Level)

The goal of this study is to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 Left Ventricular Assist System when used for the treatment of advanced, refractory, left ventricular heart failure.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (33 items).

Location: University of Alabama at Birmingham Hospital — Birmingham, Alabama

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patient's heart failure etiology is related to restrictive or constrictive physiology (e.g., nondilated hypertrophic cardiomyopathy, cardiac amyloidosis/senile or other infiltrative disease), complex congenital heart disease (e.g., transposition of the great vessels), uncorrected thyroid disease, and/or pericardial disease.
  • Patient had a myocardial infarction within seven days of study enrollment.
  • Patient had cardiothoracic surgery within 30 days of implant with the exception of a procedure to implant temporary MCS: Impella 5.5, Impella CP or TandemHeart.
  • Patient has physiological conditions or comorbidities which pose high surgical risk or obstacles as determined by the Investigator.
  • Patient has contraindications to warfarin anticoagulation.
  • Patient has known hypo- or hypercoagulable state \[e.g., disseminated intravascular coagulation (DIC)\], or has a positive heparin-induced thrombocytopenia (HIT) assay and positive serotonin release assay or requires use of a non-heparin alternative anticoagulation strategy for cardiopulmonary bypass in the judgement of the Investigator.
  • Patient is on durable MCS (e.g., LVAD or RVAD).
  • Planned need for durable or temporary RVAD support concomitant with LVAD implant.
  • Patient is on any form of pre-implant temporary MCS other than isolated LVAD support with an intra-aortic balloon pump, Impella 5.5, Impella CP, or TandemHeart.
  • Patient is on any form of pre-implant temporary MCS and has a serum lactate dehydrogenase greater than 2.5 times the upper limits of normal or plasma free hemoglobin \> 40 g/dL.
  • Patient has a history of organ transplantation.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (47 Sites)

  • University of Alabama at Birmingham Hospital — Birmingham, Alabama
  • Baptist Health Medical Center-Little Rock — Little Rock, Arkansas
  • Cedars-Sinai Medical Center — Los Angeles, California
  • UF Health Shands Hospital — Gainesville, Florida
  • Advent Health — Orlando, Florida
  • Piedmont Healthcare — Atlanta, Georgia
  • Emory University — Atlanta, Georgia
  • Advocate Christ Medical Center — Chicago, Illinois
  • Northwestern University — Chicago, Illinois
  • University of Chicago — Chicago, Illinois
  • Ascension St. Vincent Hospital - Indianapolis — Indianapolis, Indiana
  • The University Of Kansas Medical Center — Kansas City, Kansas
  • University of Kentucky — Lexington, Kentucky
  • University of Louisville — Louisville, Kentucky
  • University of Maryland Medical Center — Baltimore, Maryland
  • The Johns Hopkins Hospital — Baltimore, Maryland
  • Tufts Medical Center — Boston, Massachusetts
  • Massachusetts General Hospital — Boston, Massachusetts
  • University of Michigan — Ann Arbor, Michigan
  • Henry Ford Health — Detroit, Michigan
  • Corewell Health Grand Rapids Hospital — Grand Rapids, Michigan
  • Abbott Northwestern Hospital — Minneapolis, Minnesota
  • University of Minnesota — Minneapolis, Minnesota
  • WashU Medicine — St Louis, Missouri
  • University of Nebraska Medical Center — Omaha, Nebraska

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗