Design and rationale for the clinical investigation of a novel, magnetically levitated left ventricular assist device for the treatment of refractory heart failure

Background: Contemporary durable left ventricular assist devices (LVAD) have established current benchmarks for patient outcomes, but introduction of more novel technology is lacking. The BrioVAD System (BrioHealth Solutions, Burlington, MA) is an innovative, fully magnetically levitated pump intended to provide short-term (ST) and long-term (LT) mechanical circulatory support. Methods: The Investigation of a Novel, MagNetically Levitated VAD for the Treatment of RefractOry Left Ventricular HeArT FailurE Clinical Trial (INNOVATE) is designed to evaluate safety and efficacy of the BrioVAD by demonstrating non-inferiority to the HeartMate 3 (HM3; Abbott Labs, Chicago, IL). INNOVATE is a multi-center, prospective, non-blinded, randomized (2 BrioVAD: 1 HM3), controlled, non-inferiority study designed as a staged pivotal study with a pre-defined safety phase. Exclusion criteria are designed to enroll a patient population that aligns with contemporary clinical practice. Primary endpoints include a composite of survival to transplant, cardiac recovery, or 6 months (ST) or 24 months (LT) of LVAD support free from debilitating stroke (modified Rankin Scale > 3), or reoperation to replace the pump. A powered secondary outcome evaluates days spent in hospital, skilled nursing facility, or inpatient rehabilitation. Results: INNOVATE study screening and enrollment began in 2024. Completed enrollment of the safety cohort (n = 45) is projected in early 2025. Completion of the ST cohort (n = 237) and LT cohort (n = 402) is projected for 2026 and 2027, respectively. Conclusions: INNOVATE represents a contemporary clinical trial design evaluating unique design features of the BrioVAD System with the expectation to improve patient outcomes.