Heatley Gerald, Sood Poornima, Goldstein Daniel, Uriel Nir, Cleveland Joseph, Middlebrook Don, Mehra Mandeep R
St. Jude Medical, Minneapolis, Minnesota, USA.
St. Jude Medical, Minneapolis, Minnesota, USA.
J Heart Lung Transplant. 2016 Apr;35(4):528-36. doi: 10.1016/j.healun.2016.01.021. Epub 2016 Jan 30.
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.
HeartMate 3左心室辅助系统（LVAS；圣犹达医疗公司，前身为Thoratec公司，加利福尼亚州普莱森顿）最近被引入临床试验，用于为药物治疗无效的晚期心力衰竭患者提供持久的循环支持。这种离心式、全磁悬浮、连续流泵的设计旨在提高血液相容性并降低血液成分上的剪切应力，同时还具有内在的搏动性。尽管桥接至移植（BTT）和目标治疗（DT）是持久左心室辅助装置（LVAD）支持的既定二分法适应症，但临床实践对这些指定的适当性提出了挑战。新型LVAD技术的引入使得临床试验设计得以发展，以跟上当前的实践。前瞻性、随机的“使用HeartMate 3进行机械循环支持治疗的患者中磁悬浮技术多中心研究”（MOMENTUM 3）临床试验旨在通过证明不劣于HeartMate II LVAS（同样为圣犹达医疗公司）来评估HeartMate 3 LVAS的安全性和有效性。创新的试验设计包括根据单一的纳入和排除标准招募患者，无论该装置的预期用途如何，在短期（ST，6个月时）和长期（LT，2年时）确定结果。这种适应性试验设计包括一个预先指定的安全阶段（n = 30）分析。ST队列包括前294名患者，LT队列包括前366名患者，用于评估移植、恢复或无致残性中风（改良Rankin评分>3）的LVAD支持或再次手术更换泵的复合主要终点。作为适应性设计的一部分，独立统计学家的分析将确定在研究期间的预先指定时间是否需要调整样本量。另外662名患者将被纳入，以使评估2年时泵更换次要终点的患者总数达到1028名。
