Investigation of the BrioVAD System for the Treatment of Left Ventricular Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorBrioHealth Solutions, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BrioVAD System
- HeartMate 3
Treatment groups
780 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov