Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure (NCT06310031) | Clinical Trial Compass
RecruitingNot Applicable
Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
United States780 participantsStarted 2024-10-28
Plain-language summary
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 participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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.
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.