Momentum 3 Trial - CAP Publication | Abbott
CARDIOVASCULAR
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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

Von Willebrand Factor Degradation in HeartMate 3 vs HeartMate II LVAD

Bansal, A. Uriel, N., Colombo, P.C., Narisetty, K., Long, J.W., …Mehra, M.R. (2019). Effects of a Fully Magnetically Levitated Centrifugal-Flow or Axial-Flow Left Ventricular Assist Device on Von Willebrand Factor: A Prospective Multicenter Clinical Trial. J Heart Lung Transplant. https://doi.org/10.1016/j.healun.2019.05.006

This analysis evaluated the structure and functional characteristics of von Willebrand factor (vWF) high molecular weight multimers (HMWMs) in patients with the fully magnetically levitated centrifugal-flow HeartMate 3 (HM3) and the continuous axial-flow HeartMate II (HMII) pump. The data from this analysis demonstrates:

  • Significantly greater preservation of vWF HMWM was seen with HeartMate 3 compared to HeartMate II
  • Functional attributes of vWF are within normal range post-LVAD
  • vWF HMWM alterations but not functional changes are correlated with bleeding in HeartMate 3

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CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.