MOMENTUM 3 Trial

Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants
 

Mandeep, R.M., Cleveland, J.C., Uriel, N, Cowger J.A., Hall, S., Hostmanshof, D., …(2021). Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants. Eur J Heart Fail. https://onlinelibrary.wiley.com/doi/full/10.1002/ejhf.2211

The MOMENTUM 3 continuous access protocol (CAP) is a post-pivotal, prospective, single-arm trial designed to evaluate HeartMate 3 LVAD outcomes in 2200 implanted patients (515 pivotal trial and 1685 CAP patients). The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial. The study was designed to address the following:

• Assess if the larger HM3 LVAD experience is associated with reproducible or improved outcomes by evaluating difference between the early pivotal trial experience and the post-trial experience
• Determine if HM3 LVAD survival differs by clinical severity at implant or by therapeutic goal based on transplant eligibility
• Outline the net burden of major adverse events (as well as their individual components) over the course of this clinical experience