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

Recruiting now · Not applicable

Conditions studied: Cardiovascular Diseases, Heart Diseases, Heart Failure

In brief

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.

Key facts

Study ID

NCT06310031

Run by

BrioHealth Solutions, Inc.

People needed

780

Starts

2024-10-28

Expected to finish

2028-12-01

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is ≥ 18 years of age.
• Patient has received institutional approval for LVAD implantation.
• Patient has a body surface area (BSA) ≥ 1.2 m2.
• Patient is classified as NYHA Class IV with advanced heart failure refractory to advanced heart failure management or NYHA Class III with dyspnea upon mild physical activity.
• Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF < 30% on inotropes or temporary MCS.
• Patient is inotrope dependent, OR has a cardiac index (CI) ≤ 2.2 liters/min/m2, while not on inotropes, and also meets one of the following criteria:
• Is on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and is failing to respond or is not able to tolerate OMM; or
• Has advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) or temporary mechanical circulatory support device (MCSD) for at least seven days.
• Patient has provided voluntary and informed consent.
• Females of childbearing age agree to use adequate contraception and have a negative pregnancy test.

You may not qualify if…

• 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.
• Patient has a mechanical aortic valve that may not be converted to a bioprosthetic valve at the time of VAD implant.
• Patient has a platelet count < 50 k/μl.
• Patient has a history of confirmed untreated abdominal aortic aneurysm (AAA) > 5 cm in diameter.
• Patient has moderate or severe aortic insufficiency that will not be corrected during the VAD implant procedure.
• Patient has an uncontrolled systemic infection.
• Patient has a positive COVID 19 test within 21 days of study enrollment and at least one high risk feature including need for supplemental oxygen or ferritin >1000 ug/L.
• Patient has severe end-organ dysfunction as evidenced by one or more of the following criteria:
• Total bilirubin > 3.0 mg/dL or cirrhosis confirmed by liver imaging or hemodynamic assessment with or without biopsy confirmation.
• International normalized ratio (INR) ≥ 2.0 or PTT > 2.5 times control that is not related to anticoagulation therapy.
• Glomerular filtration rate (GFR) < 30 mL/ min/1.73 m2 or need for renal replacement therapy.
• Severe pulmonary arterial hypertension with a pulmonary vascular resistance (PVR) ≥ 8 Wood units that is not acutely reversible with pharmacologic intervention.
• Severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease requiring home oxygen or an FEV1/FVC < 0.7 and FEV1 < 40% predicted.
• Mechanical ventilation for more than three days present at the time of study enrollment.
• Documented history of pulmonary embolism or pulmonary infarct within 60 days of study enrollment.

Where it is running

• Baptist Health Medical Center-Little Rock — Little Rock, Arkansas, United States (enrolling)
• UF Health Shands Hospital — Gainsville, Florida, United States (enrolling)
• Advent Health — Orlando, Florida, United States (enrolling)
• Piedmont Healthcare — Atlanta, Georgia, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Advocate Christ Medical Center — Chicago, Illinois, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Ascension St. Vincent Hospital - Indianapolis — Indianapolis, Indiana, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• Henry Ford Health — Detriot, Michigan, United States (enrolling)
• Corewell Health Grand Rapids Hospital — Grand Rapids, Michigan, United States (enrolling)
• Abbott Northwestern Hospital — Minneapolis, Minnesota, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• WashU Medicine — St Louis, Missouri, United States (enrolling)
• University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
• Newark Beth Israel Medical Center — Newark, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Mount Sinai — New York, New York, United States (enrolling)
• Columbia University Irving Medical Center/ New York Presbyterian Hospital — New York, New York, United States (enrolling)
• Montefiore Medical Center — The Bronx, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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