Adult (>18 years old), advanced heart failure NYHA Class IV patients who are refractory to advanced heart failure management and meet study Inclusion/Exclusion criteria will be enrolled.

The objective of the study is to evaluate the safety and effectiveness of the EVA2 by demonstrating non-inferiority to commercially approved LVADs when used for the treatment of refractory NYHA Class IV heart failure.

Subjects will be followed for 6 months (short-term cohort) and 24 months (long-term cohort) after EVA2/HM3 LVAS implantation or until outcome events of transplantation, explantation, death or withdrawal, whichever occurs first. Whereas subjects experiencing the outcome events of "Severe RHF" and "Disabling stroke" will remain in study follow-up.

Peri-operative complications and any failure to successfully implant the device.

All adverse events occurring during the acute and chronic phase of the study (frequency, severity, duration, sequelae and relationship to device).

All adverse events occurring during the extension phase (frequency, severity, duration, sequelae and relationship to device).

Documented mucosal (GI tract and/or nasopharynx) bleeding, requiring blood transfusion (backed red blood cells) or hemoglobin drop (>2 g/dL) without another identifiable source of bleeding AND meet one or more of the following:

• Identified mucosal bleeding by endoscope
• Appearance of overt melena, hematochezia, hematemesis, epistaxis
• Occult bleeding as evidenced by hemoccult-positive stool (2 consecutive testing to avoid false positive)

Inclusion Criteria:

The following is a list of general inclusion criteria:

• Age ≥ 18 years
• Left Ventricular Ejection Fraction (LVEF) ≤ 25%
• NYHA Class IV heart failure
• Patient is able to provide written informed consent
• More detailed inclusion criteria information is noted in the study protocol

Exclusion Criteria:

The following is a list of general exclusion criteria:

• Active, uncontrolled infection
• Severe end organ dysfunction or failure
• History of any organ transplant
• Prosthetic mechanical aortic valve that will not be converted to a bioprosthesis
• Patients with an unacceptable risk for successful LVAD implantation and maintenance
• Patients refusing blood transfusion
• Intolerant of anticoagulation therapy
• Active psychiatric disorder, irreversible cognitive dysfunction or other psychosocial behavior that impairs the ability of the patient to follow instructions, maintain their device or their medical regimen
• Pregnancy
• Current dependence on other mechanical circulatory support device at the time of implant, other than IABP and Impella 5.0/5.5
• Presence of condition other than heart failure that would limit survival to less than 24 months
• More detailed exclusion criteria information is noted in the study protocol