Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure

Prior treatment

• Technical obstacles to LVAD or CardioMEMS implantation which pose an inordinately high surgical risk, in the judgment of the implanter.
• Presence of mechanical aortic valve that will not be either converted to a bioprosthesis or oversewn at the time of LVAD implant.
• History of pulmonary embolism within 30 days prior to enrollment or history of recurrent (\>1 episode) pulmonary embolism and/or deep vein thrombosis.
• Planned VAD or Bi-VAD support prior to enrollment.

Other illness

• Etiology of HF due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy.
• History of any solid organ transplant.
• Psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and LVAS management.
• Presence of an active, uncontrolled infection.
• Complex congenital heart disease.
• Any condition other than HF that could limit survival to less than 24 months.

Lab values

• Presence of any one of the following risk factors for or indications of severe end organ dysfunction or failure:
  • An INR ≥ 2.0 not due to anticoagulation therapy
  • An eGFR \< 30 mL/min/1.73 m2 and nonresponsive to diuretic therapy or receiving chronic dialysis.
  • Biopsy proven liver cirrhosis.
  • Need for chronic renal replacement therapy.
  • History of severe chronic obstructive pulmonary disease (COPD) defined by Forced Expiratory Volume FEV1 \< 30% predicted.
  • History of cerebrovascular disease with significant (\> 80%) uncorrected internal carotid stenosis.
  • Significant peripheral vascular disease (PVD) accompanied by ischemic rest pain or extremity ulceration.

Age

• Subject is \< 18 years of age at the time of informed consent.

Other

• Dependent on IV inotrope in the last 30 days.
• Contra-indications to HM3 LVAS or CardioMEMS HF system.
• Existence of ongoing MCS.
• Currently Pregnant or capable of becoming Pregnant and Unwilling to Use Contraception with LVAD.
• Participation in any other clinical investigation with an active treatment arm that is likely to confound study results or affect the study outcome.

• Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure
• LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m²
• Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value)
• NYHA Class IIIB or NYHA Class IV
• Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months
• Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant
• Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group
  • Randomization Criteria:
• Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
• 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.
• mean PAP ≥ 30 mmHg.
• The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant.
  • Single Arm Registry Criteria:
• Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.
• 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.
• mean PAP \<30 mmHg