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

Ki vehet részt

• 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

Ki nem vehet részt

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