MOMENTUM 3 IDE Clinical Study Protocol (HM3)

The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.

Primary Outcome Measures:

• Short Term Survival [ Time Frame: The first 294 randomized Subjects will be followed for 6 months or to outcome (transplant, explant, or death), whichever occurs first. ]

  Composite of Survival to transplant, recovery or 6 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump, HM II used as control

• Long Term Survival [ Time Frame: The first 366 Subjects will be followed for 24 months or to outcome (transplant, explant, or death), whichever occurs first. ]

  Composite of Survival to transplant, recovery or 24 months of LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump, HM II used as control

Secondary Outcome Measures:

• EuroQoL 5D-5L (EQ-5D-5L) [ Time Frame: Baseline and Months 1, 3, 6, 12, 18 and 24 ]

  Quality of Life as measured by EuroQoL 5D-5L (EQ-5D-5L) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: Baseline and Months 3, 6, 12, 18 and 24 ]

  Quality of Life as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Six Minute Walk Test (6MWT) [ Time Frame: Baseline and Months 1, 3, 6, 12, 18 and 24 ]

  Functional status as measured by the Six Minute Walk Test (6MWT) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• NYHA [ Time Frame: Baseline, Discharge, and Months 1, 3, 6, 12, 18 and 24 ]

  Functional status as measured by NYHA classification will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Reoperations [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of all reoperations will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Rehospitalizations [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of all rehospitalizations will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Device Malfunctions [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of device malfunctions will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Bleeding [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of all bleeding events will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Cardiac Arrhythmias [ Time Frame: As they occur up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of all Cardiac Arrhythmias will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Pericardial Fluid Collection [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Pericardial Fluid Collection will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Device Thrombosis [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Device Thrombosis will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Hemolysis [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Hemolysis will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Hepatic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Hepatic Dysfunction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Hypertension [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Hypertension will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Major Infection [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Major Infection will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Myocardial Infarction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Myocardial Infarction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Neurologic Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Neurologic Dysfunction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Psychiatric Episode [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Psychiatric Episode will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Renal Dysfunction [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Renal Dysfunction will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Respiratory Failure [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Respiratory Failure will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Right Heart Failure [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Right Heart Failure will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Arterial Non-CNS Thromboembolism [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Arterial Non-CNS Thromboembolism will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Venous Thromboembolism Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Venous Thromboembolism Event will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Wound Dehiscence [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Wound Dehiscence will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

• Other Adverse Event [ Time Frame: As it occurs up to 24 months or to outcome, whichever occurs first ]

  Frequency and incidence of Other Adverse Events that cause clinically relevant changes in the Subject's health (e.g. cancer) will be analyzed at 6 months (Short Term Indication) and 24 months (Long Term Indication). HM II is the comparator

Other Outcome Measures:

• Pump Replacement [ Time Frame: As they occur up to 24 months or to Outcome, whichever occurs first ]

  In addition to powering the study on the primary endpoints for PMA approval, the study will pre-specify a powered secondary endpoint to evaluate incidence of pump replacements at 24 months. HM II is the comparator