Use of the Impella BTR™ in Patients With Heart Failure: An Early Feasibility Study

Prior treatment

• New diagnosis of heart failure ≤90 days prior to enrollment
• Previous aortic valve replacement or reconstruction
• STEMI ≤30 days prior to enrollment
• Severe Cardiogenic Shock during index hospitalization - requiring multiple pressors, currently on mechanical circulatory support (not including IABP) or mechanical ventilation or experiencing PEA or refractory VT/VF
• Unwitnessed cardiac arrest OR ≥30 minutes of CPR prior to enrollment OR any cardiac arrest with impairment in mental status, cognition or any global or functional neurological deficit.
• Known contraindication to heparin (i.e., heparin induced thrombocytopenia (HIT)), pork, pork products, contrast media or study required medication(s)
• Intolerance to anticoagulant or antiplatelet therapies
• Subject is currently on dialysis
• Prior cardiac surgery ≤90 days prior to enrollment
• RV dysfunction requiring mechanical or inotropic support pre-device implant
• History of stroke or intracranial hemorrhage ≤90 days prior to enrollment, or a history of cerebrovascular disease with significant (\> 80%) uncorrected carotid stenosis, or any permanent neurological deficit
• Subject has previously been symptomatic with or hospitalized for COVID-19 unless he/she has been discharged (if hospitalized) and asymptomatic for ≥8 weeks and has returned to his/her prior baseline (pre-COVID) clinical condition
• Participation in the active treatment or follow-up phase of another clinical study of an investigational drug or device which has not reached its primary endpoint

Other illness

• Subjects with known aortic diseases
• Infection of the proposed procedural access site or suspected systemic active infection
• History of bleeding diathesis or known coagulopathy, any recent GU or GI bleed or will refuse blood transfusions
• History of heart transplant
• Pre-existing pulmonary disease requiring home oxygen

Lab values

• Prealbumin \<150 mg/L (15 mg/dL) or Albumin \<30 g/L (3 g/dL)
• Known hemoglobin diseases, such as sickle cell anemia or thalassemia

Other

• Structural aortic valve regurgitation or stenosis of any grade greater than mild, with evidence of aortic sclerosis on pre-procedure echocardiography
• Thrombus in the left atrium or ventricle
• Any contraindication that precludes placing an Impella® including tortuous vascular anatomy, axillary artery diameter \<7 mm
• Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade
• Pre-existing liver dysfunction defined as: Child-Pugh Class B or C
• Suspected or known pregnancy
• Subject has other medical, social or psychological problems that, in the opinion of the Investigator, compromises the subject's ability to give written informed consent and/or to comply with study procedures
• Subject belongs to a vulnerable population \[Vulnerable subject populations are defined as individuals with mental disability, persons in nursing homes, children, impoverished persons, homeless persons, nomads, refugees and those permanently incapable of giving informed consent.\]

• Age ≥18 years
• Subject has signed the Informed Consent
• Subject has pre-existing heart failure, with NYHA Class IV prior to the index admission
• Subject is presenting with acute heart failure and meets one of the following criteria:
  • Sustained episode of systolic blood pressure ≤90 mmHg for at least 30 minutes or need for vasoactive agents to maintain such blood pressure
  • Or a cardiac index (CI) \<2.2 L/min/m2 determined to be secondary to cardiac dysfunction, in the absence of hypovolemia
  • Or required support with an intra-aortic balloon pump