Inclusion Criteria  

• Primary arm
  • Life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 4)
  • Ineligible for cardiac transplantation (e.g., contraindication to immunosuppression, cancer, elevated panel reactive antibodies [PRAs]) as determined by the implanting center at time of implant screening assessment
  • On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
  • Between 19 and 75 years of age
  • Body Surface Area (BSA) of ≥ 1.7m2
  • Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments
• Secondary arm
  • Are NOT eligible to participate in the Primary Arm
  • Have life-threatening, irreversible biventricular heart failure (Intermacs Patient Profile Classifications 1 - 7)
  • Ineligible for cardiac transplantation (as determined by the implanting center at time of implant screening assessment)
  • On optimal medical management and failing to respond or failing DT VAD therapy (continuing to decline)
  • 19 years of age or older
  • Sternum to T10 distance > 10cm OR adequate room in chest as determined by 3-D imaging assessment or by other standard clinical assessments

Exclusion Criteria

• Primary arm
  • Cardiac transplant-eligible
  • Cannot be adequately anticoagulated on the Temporary total artificial heart
  • Have insufficient space in the chest
  • On ECMO support
  • Have cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
  • Acute or chronic renal dysfunction (per Intermacs AE Definitions)
  • Have cardiac cachexia (e.g., pre-albumin <17, fragility, and catabolic/anabolic imbalance)
  • A comorbidity that has a poor prognosis of survival beyond six months
  • Insufficient social support 
  • Have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)
•  Secondary arm
  • Less than 19 years old
  • Cardiac transplant-eligible patients
  • Have cirrhosis (evidenced by ultrasound, CT scan, or positive biopsy)
  • Have chronic renal dysfunction (per Intermacs AE Definitions)
  • Insufficient space in the chest
  • Cannot be adequately anticoagulated on the Temporary Total Artificial Heart
  • Insufficient social support
  • Have demonstrated non-compliance with medical instructions (as determined by the Principal Investigator)