Use of the Impella BTRâ„¢ in Patients With Heart Failure: An Early Feasibility Study

Inclusion Criteria:

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

Exclusion Criteria:

Structural aortic valve regurgitation or stenosis of any grade greater than mild, with evidence of aortic sclerosis on pre-procedure echocardiography
New diagnosis of heart failure ≤90 days prior to enrollment
Previous aortic valve replacement or reconstruction
Prealbumin <150 mg/L (15 mg/dL) or Albumin <30 g/L (3 g/dL)
Thrombus in the left atrium or ventricle
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.
Subjects with known aortic diseases
Any contraindication that precludes placing an Impella® including tortuous vascular anatomy, axillary artery diameter <7 mm
Infection of the proposed procedural access site or suspected systemic active infection
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
History of bleeding diathesis or known coagulopathy, any recent GU or GI bleed or will refuse blood transfusions
Known hemoglobin diseases, such as sickle cell anemia or thalassemia
Subject is currently on dialysis
History of heart transplant
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
Restrictive or obstructive cardiomyopathy, constrictive pericarditis, restrictive pericarditis, pericardial tamponade
Pre-existing liver dysfunction defined as: Child-Pugh Class B or C
Pre-existing pulmonary disease requiring home oxygen
Suspected or known pregnancy
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
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
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
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.]