Trial to Evaluate Safety and Effectiveness of Mechanical Circulatory Support in Patients with Advancing Heart Failure

Eligibility Criteria

• 1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure.
• 2. LVEF ≤30% and Cardiac Index \< 2.2 L/min/m².
• 3. Limited functional status as demonstrated by 6MWT \< 300 m due to HF related reasons.
• 4. NYHA Class IIIB or NYHA Class IV
• 5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months.
• 6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant.
• 7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group
• 1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
• 2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
• 3. mean PAP ≥ 30 mmHg.
• 4. The patient will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.
• 1. mean PAP \<30 mmHg
• 1. Subject is \< 18 years of age at the time of informed consent.
• 2. Any use of inotrope therapy in the last 30 days.
• 3. Contra-indications to HM3 LVAS or CardioMEMS HF system.
• 4. Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, severe valvular heart disease, or restrictive cardiomyopathy.
• 5. Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
• 6. Existence of ongoing MCS.
• 7. Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
• 8. History of any solid organ transplant.
• 9. Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
• 10. Presence of an active, uncontrolled infection.
• 11. Complex congenital heart disease.
• 12. Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
• 13. History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis.
• 14. Planned VAD or Bi-VAD support prior to enrollment.
• 15. Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:
• 1. An INR ≥ 2.0 not due to anticoagulation therapy
• 2. An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
• 3. Biopsy proven liver cirrhosis.
• 4. Need for chronic renal replacement therapy.
• 5. History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted.
• 6. History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis.
• 7. Significant peripheral vascular disease (PVD) accompanied by rest pain or extremity ulceration.
• 16. Any condition other than HF that could limit survival to less than 24 months.
• 17. Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.