| Eligibility |
Inclusion Criteria:
1. Age = 18 years and = 90 years
2. Subject has signed the informed consent
3. Scheduled for an elective or urgent high risk percutaneous coronary intervention with
hemodynamic support
Exclusion Criteria:
1. Aortic valve disease that is anticipated to be prohibitive to Impella ECP crossing,
including greater than mild aortic stenosis
2. Previous aortic valve replacement or reconstruction
3. Thrombus in left ventricle
4. Subjects with known aortic vessel disease or with aortic dissection
5. Any contraindication that precludes placing an Impella including aortic, iliac or
femoral disease such as tortuosity, extensive atherosclerotic disease or stenosis
6. Prior stroke with any permanent neurologic deficit or any prior intracranial
hemorrhage or any prior subdural hematoma or known intracranial pathology
pre-disposing to intracranial bleeding, such as an arteriovenous malformation or mass
7. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
Cardiogenic shock is defined as: systemic hypotension (systolic BP <90 mmHg or the
need for inotropes/pressors to maintain a systolic BP >90 mmHg) plus one of the
following: any requirement for pressors/inotropes prior to arrival at the
catheterization laboratory, clinical evidence of end-organ hypoperfusion or use of
IABP or any other circulatory support device
8. Infection of the proposed procedural access site or suspected systemic active
infection, including any fever
9. 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
10. Known contraindication to heparin (i.e., heparin-induced thrombocytopenia), contrast
media or Study-required medication(s) (i.e., aspirin)
11. Platelet count <75k, bleeding diathesis, coagulopathy or unwilling to receive blood
transfusions
12. Subject is on dialysis
13. Suspected or known pregnancy
14. 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
15. 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
16. 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. Vulnerable populations also may include members
of a group with a hierarchical structure such as university students, subordinate
hospital and laboratory personnel, employees of the Sponsor, members of the armed
forces and persons kept in detention]
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