HeartMate 3 Left-ventricular Assist System (Photo: Business Wire)
The MOMENTUM 3 IDE study is a prospective, multi-center, randomized, unblinded, study evaluating the safety and effectiveness of the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure. More than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure are participating in the study. Patients are being followed for a short-term endpoint of six months, and a long-term endpoint of two years. Current data show the results at the six-month follow-up in the first 294 patients enrolled. The primary endpoint for the study was six months survival with freedom from disabling stroke and reoperation to repair or replace the device. The study met its primary endpoint (non-inferiority P<0.0001; superiority P=0.037). There were no pump thrombosis events reported in patients who were implanted with HeartMate 3 LVAS at six months, confirming the results observed with the HeartMate 3 LVAS in the CE Mark trial. Rates of all other adverse events were similar between the HeartMate 3 LVAS and historical rates seen in the HeartMate II LVAS, which is the most widely used and extensively studied LVAD commercially available. This study included all-comers, which means researchers evaluated the device regardless of whether the patient needed a short-term support option while awaiting transplantation or a long-term support option for those who are not candidates for cardiac transplantation. "The Heartmate 3 LVAS improved clinical outcomes in the MOMENTUM 3 study by avoiding the need for surgical reoperation to replace or remove the pump due to pump thrombosis," said Dr. Mandeep R. Mehra, medical director of Brigham and Women's Hospital Heart and Vascular Center in Boston. "More importantly, these clinical gains occurred without an increase in other adverse events, providing important therapeutic progress for our advanced heart failure patients."