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  • Clinical trial design and rationale of the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) investigational device exemption clinical study protocol
    Heatley, Gerald ...
    The HeartMate 3 left ventricular assi st system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circul atory ... support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous- fl ow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transp lant (BTT) and destination therapy (DT) are established dichotomous indications for durable le ft ventricular assist device (LVAD) supp ort, clinical practice has challenged the appropriateness of these designations. The introduction of novel LVAD technology allows for the development of clinical trial designs to keep pace with current prac tices. The prospective, randomized Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) clinical trial aims to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HeartMate II LVAS (also St. Jude Medical, Inc.). The innovative trial design includes patients enrolled under a single inclusion and exclusion criteria , regardless of the intended use of the device, with outcomes ascertained in the short term (ST, at 6 months) and long term (LT, at 2 years). This adaptive trial design includes a pre-speci fi ed safety phase ( n % 30) analysis. The ST cohort includes the fi rst 294 patients and the LT cohort includes the fi rst 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD suppor t free of debilitating stroke (modi fi ed Rankin score 4 3), or re-operation to replace the pump. As part of the adaptive design, an anal ysis by an independent statistician will determine whether sample size adjustment is required at pre-speci fi ed times during the study. A further 662 patients will be enrolled to reach a total of 1,028 patients for evaluation of the secondary end-point of pump replacement at 2 years.
    Vir: Journal of heart and lung transplantation. - ISSN 1053-2498 (Vol. 35, iss. 4, Apr. 2016, str. 528-536)
    Vrsta gradiva - članek, sestavni del
    Leto - 2016
    Jezik - angleški
    COBISS.SI-ID - 33129945

    Povezava(-e):

    http://www.sciencedirect.com/science/article/pii/S1053249816000693
    DOI

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