title: 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.
abstract: The HeartMate 3 left ventricular assist system (LVAS; St. Jude Medical, Inc., formerly Thoratec Corporation, Pleasanton, CA) was recently introduced into clinical trials for durable circulatory support in patients with medically refractory advanced-stage heart failure. This centrifugal, fully magnetically levitated, continuous-flow pump is engineered with the intent to enhance hemocompatibility and reduce shear stress on blood elements, while also possessing intrinsic pulsatility. Although bridge-to-transplant (BTT) and destination therapy (DT) are established dichotomous indications for durable left ventricular assist device (LVAD) support, 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 practices. 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-specified safety phase (n = 30) analysis. The ST cohort includes the first 294 patients and the LT cohort includes the first 366 patients for evaluation of the composite primary end-point of survival to transplant, recovery or LVAD support free of debilitating stroke (modified Rankin score >3), or re-operation to replace the pump. As part of the adaptive design, an analysis by an independent statistician will determine whether sample size adjustment is required at pre-specified 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.
authors.affiliation: St. Jude Medical, Minneapolis, Minnesota, USA. Electronic address: jerry.heatley@thoratec.com.
authors.forename: Gerald
authors.initials: G
authors.lastname: Heatley
authors.affiliation: St. Jude Medical, Minneapolis, Minnesota, USA.
authors.forename: Poornima
authors.initials: P
authors.lastname: Sood
authors.affiliation: Department of Cardiothoracic Surgery, Montefiore Medical Center, New York, New York, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Goldstein
authors.affiliation: Division of Cardiology, University of Chicago, Chicago, Illinois, USA.
authors.forename: Nir
authors.initials: N
authors.lastname: Uriel
authors.affiliation: Department of Surgery, University of Colorado Anschutz Medical Center, Denver, Colorado, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Cleveland
authors.affiliation: St. Jude Medical, Minneapolis, Minnesota, USA.
authors.forename: Don
authors.initials: D
authors.lastname: Middlebrook
authors.affiliation: Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts, USA.
authors.forename: Mandeep R
authors.initials: MR
authors.lastname: Mehra
mesh_terms: D006801:Humans; D004867:Equipment Design; D006333:Heart Failure / Q000628:therapy; D006353:Heart-Assist Devices; D015337:Multicenter Studies as Topic / Q000379:methods; D016032:Randomized Controlled Trials as Topic
keywords: HeartMate 3; LVAD; MOMENTUM 3; MagLev; advanced heart failure