PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management

简要总结

详细描述

主要结局

次要结局

• Survival on LVAD support at six months post HM II implantation(6 months)
• Multivariate analysis of risk factors for pump thrombosis including demographics, anti-coagulation regimen, selected laboratory data (INR, LDH, plasma free Hgb), pump position measures, pump parameters and blood pressure(Baseline and 1 week, 1 month, 3 months and 6 months after surgery)
• Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation(3 and 6 months)
• Incidence of protocol-defined anticipated adverse events(Baseline, 1 month , 3 months and 6 months after surgery)
• Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation(3 and 6 months)
• Characterization of pump position in the study population (measured via quantitative assessment of X-ray images including inflow cannula angle, outflow cannula angle and pump pocket depth)(1 week and 6 months after surgery)
• Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation(Baseline and 3 months after implant)
• Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population(Baseline, 1 week (plus or minus 3 days), 1 month (plus or minus 7 days), 3 months and 6 months (plus or minus 30 days) after surgery)
• Characterization of pump parameters in the study population including power (watts), speed (rpm), flow (L/min), and pulsatility index(1 week, 1 month, 3 months, and 6 months after surgery)
• Incidence of confirmed pump thrombosis within six months of HM II implantation(6 months)