Refractory Left Ventricular Heart Failure Treatment-resistant heart failure
Conditions
Interventions
The BrioVAD 
Pump is a small implantable blood pump designed to assist your heart’s weakened left ventricle, which is the primary pumping chamber of the heart, responsible for delivering oxygenated blood and essen
Pump 
uses a magnetically levitated rotor, which is a round disk that has engineered pumping features (called vanes) meant to gently move blood from the left side of the heart to the body’s main artery, the
This design was developed to eliminate friction between the rotor and the outer shell of the blood pump which can cause damage to sensitive blood cells or proteins, while providing the needed blood fl
BrioVAD 
System 
includes a percutaneous driveline, which is a small tube that contains wires needed to operate the pump that passes through the skin and connects to a driveline cable that is attached to an external s
A power source is also connected to the controller, which may be either a rechargeable battery or regular household power and is used to run the pump and maintain communication between the pump and th
 
Sponsors
BrioHealth BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patient is = 18 years of age.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 mechanical circulatory support (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; orHas advanced heart failure for at least 14 days and is dependent on an intra-aortic balloon pump (IABP) 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.
Exclusion criteria
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.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 LV support with an intra-aortic balloon pump.Patient is on IABP pre-implant with a serum lactate dehydrogenase greater than 2.5 times the upper limits of normal or with 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.History of stroke within 90 days of study enrollment or history of stroke with a mRS = 3 at the time of study enrollment.Symptomatic cerebrovascular disease and/or uncorrected carotid stenosis > 80%.Significant peripheral vascular disease (PVD) accompanied by pain at rest or ext
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the survival rate at 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following will be evaluated at 6, 12 and 24 monthsComposite of survival to transplant, recovery, or LVAS support free of debilitating stroke (mRS > 3), or reoperation to replace the pump.Evaluation of safety using INTERMACS adverse event (AE) terms and definitions, heart transplantation, LVAD explant or decommission, study withdrawal, or death, whichever occurs first.BrioVAD Controlled Operating Parameters (Estimated Pump Flow Rate (LPM), Pump Speed (RPM), and Power Consumption (watts)) and Cardiac Output (CO) through the aorta measured with ECHO.Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) and Kansas City Cardiomyopathy Questionnaire (KCCQ)Functional status as measured by the 6-minute walk test (6MWT)NYHA classificationFrequency and incidence of re-operationsFrequency and incidence of device malfunctionFrequency and incidence of rehospitalizationsTotal number of nights in hospital, or inpatient rehabilitation, inclusive of index hospitalization, heart transplantation, LVAS explant or decommission, study withdrawal, or death, whichever occurs first. | — |
Countries
Austria, Germany, Netherlands
Contacts
Public ContactH Verhoeven
BrioHealth BV
Outcome results
None listed