The MOMENTUM 3 (Multicenter Study of MagLev™ Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3™) investigational device exemption (IDE) clinical study was designed to evaluate the safety and effectiveness of HeartMate 3™ Left Ventricular Assist System (LVAS) by demonstrating non-inferiority to the HeartMate II™ LVAS when used for the treatment of advanced refractory left ventricular heart failure.
MOMENTUM 3 is a multicenter, prospective, randomized, pivotal study with an innovative trial design. Patients were enrolled under a single inclusion and exclusion criteria, regardless of the intended use of the device. Outcomes were evaluated in the short term at six months in the first 294 enrolled patients. An additional 72 patients (total of 366 patients- long-term cohort) were enrolled for evaluation of long-term outcomes at two years. Finally, an additional 662 patients (total of 1028 patients—full cohort) were enrolled to evaluate pump reliability at two years. Enrollment began in September 2014 and the two-year study follow-up has been completed. Following enrollment of the pivotal trial, an additional 1685 patients underwent implant with the HeartMate 3 LVAS and were enrolled in the MOMENTUM 3 Continued Access Protocol (CAP) study.
MAT-2006843 v1.0
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