A prospective, multi-center randomized non-inferiority study, COMPETENCE Trial, is underway to assess non-inferiority of the EVA2 to the HeartMate 3 LVAS when used for the treatment of refractory advanced heart failure. The primary end-point is a composite of the individual primary outcomes: Survival to cardiac transplant or device explant for recovery; Free from disabling stroke; Free from severe Right Heart Failure after implantation of original device. Randomization is in a 2:1 (EVA2:HM3) ratio.
The first patient was enrolled into the COMPETENCE Trial in December of 2020, and 25 subjects (16 EVA2 and 9 HM3) are currently enrolled. Enrollment of a safety cohort is projected to be completed by third quarter of 2022 at which time an interim analysis will be performed. Short-term cohort (92 EVA2 subjects) and long-term cohort is expected to be completed by the end of 2023 and 2024, respectively.
The design features of the EVA2 such as a novel inflow cannula and large blood gaps may improve clinical outcomes but require further study. The ongoing COMPETENCE trial is designed to determine if the EVA2 is non-inferior to the HM3.
方法:前瞻性,多中心随机非劣效性研究,能力审判,正在评估EVA2用于治疗难治性晚期心力衰竭时对HeartMate3LVAS的非劣效性。主要终点是个体主要结局的复合:心脏移植或装置外植体存活恢复;无致残性中风;植入原始装置后无严重右心衰竭。随机化的比例为2:1(EVA2:HM3)。
结果:首例患者于2020年12月参加了能力试验,目前纳入了25名受试者(16名EVA2和9名HM3)。安全性队列的招募预计将在2022年第三季度完成,届时将进行中期分析。短期队列(92名EVA2受试者)和长期队列预计分别于2023年底和2024年底完成。
结论:EVA2的设计特点,如新型流入套管和大的血液间隙,可能会改善临床结果,但需要进一步研究。正在进行的能力试验旨在确定EVA2是否低于HM3。