A Comparative Analysis of Long-Term Outcomes in the MOMENTUM 3 Pivotal Trial and Continued Access Protocol Post-Approval Study Phase: A Study of over 1500 HeartMate 3 Implants

Abstract

Purpose The MOMENTUM 3 pivotal trial conducted from 2014 to 2018 evaluated safety and effectiveness of the HeartMate 3 (HM3) left ventricular assist system (LVAS) compared to the HeartMate II pump. The trial demonstrated superiority of the HM3 LVAS for the primary endpoint of survival free of disabling stroke or reoperation to replace a malfunctioning pump at 2-years. HM3 LVAS superiority was due to improved hemocompatibility with near-elimination of device thrombosis, halving of stroke rates, and a decrease in gastrointestinal bleeding rates compared to the control device. Once enrollment for the pivotal trial was completed, and prior to FDA approval of the HM3 LVAS, the MOMENTUM 3 Continued Access Protocol (CAP) was initiated in 2016 as a single arm study to evaluate the HM3 LVAS in the post-approval phase using similar entry criteria as the pivotal trial. We plan to compare 2-year outcomes from the first 1000 CAP patients to the 515 patients implanted with HM3 in the pivotal trial. We hypothesize that clinical outcomes from the CAP cohort (post-approval phase) will be comparable or better to early results observed in the pivotal trial. Methods The MOMENTUM 3 CAP is a single arm, prospective study conducted at 68 centers that participated in the pivotal trial and designed as the post-approval study phase of the trial. Entry criteria for MOMENTUM 3 CAP matched those of the pivotal trial until FDA approval for short-term HM3 use was granted in August 2017. BTT patients were subsequently excluded from the CAP cohort starting in October 2017 and only transplant ineligible patients were enrolled afterwards. Baseline demographics and 2-year outcomes will be compared between the pivotal trial and CAP cohorts. The data lock will be performed in December 2020 with results available by March 2021. Endpoints These trial findings will include the first presentation of the largest comprehensive comparative analysis of long-term outcomes in over 1500 HM3 patients from the MOMENTUM 3 pivotal trial and CAP cohorts with respect to survival, adverse events, quality of life and functional status at 2 years. The findings will inform the field on whether “within trial” findings are preserved in the “post-approval” phase and account for temporal changes in medical and surgical management with the HM3 LVAS. (MOMENTUM 3 and CAP funded by Abbott)