Investigation of a Novel, magNetically Levitated VAD for the Treatment of refractOry Left Ventricular heArT failurE
BrioHealth Solutions, Inc.
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.
Description
The INNOVATE Trial is a prospective, non-blinded, randomized, controlled, multi-center, non-inferiority study to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3™ (HM3) LVAS (Abbott) when used for the treatment of advanced, refractory left ventricular heart failure. It is the first clinical study to compare two left ventricular assist devices (LVAD) that belong to the same category of fully magnetically levitated LVAD.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient is ≥ 18 years of age. 2. Patient has received institutional approval for LVAD implantation. 3. Patient has a body surface area (BSA) ≥ 1.2 m2. 4. 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. 5. Patient has a left ventricular ejection fraction (LVEF) ≤ 25% or LVEF \< 30% on inotropes or temporary MCS. 6. 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 fol…
Interventions
- DeviceBrioVAD System
Implantation of the BrioVAD System to evaluate the safety and efficacy of the BrioVAD System by demonstrating non-inferiority to the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure.
- DeviceHeartMate 3
Implantation of the commercially approved HeartMate 3 LVAS, which is the standard treatment for advanced heart failure.
Locations (37)
- Baptist Health Medical Center-Little RockLittle Rock, Arkansas
- UF Health Shands HospitalGainsville, Florida
- Advent HealthOrlando, Florida
- Piedmont HealthcareAtlanta, Georgia
- Emory UniversityAtlanta, Georgia
- Advocate Christ Medical CenterChicago, Illinois