Door To Unloading With IMPELLA CP System in Acute Myocardial Infarction - Safety and Feasibility Study

A multi-center, prospective, randomized, two-arm feasibility trial to assess the potential
role of unloading with the Impella CP prior to revascularization in reducing infarct size.
The study design includes 1:1 randomization between: 1) Delay Arm: 30 minutes of unloading
with Impella CP prior to primary percutaneous coronary intervention (PPCI); and 2) Immediate
Arm: initiation of Impella CP unloading followed immediately by PPCI.

Study Hypothesis: Direct active unloading of the left ventricle with the Impella CP System
prior to PPCI in patients with ST-elevation myocardial infarction (STEMI) is safe and
feasible

Main Inclusion Criteria:

- Age 21-80 years

- First myocardial infarction

- Acute anterior STEMI with ≥ 2 mm in 2 or more contiguous anterior leads or≥ 4 mm total
ST-segment deviation sum in the anterior leads

- Signed Informed Consent

Main Exclusion Criteria:

- Cardiogenic shock defined as: systemic hypotension (systolic BP less than 90 mmHg or
the need for inotropes/pressors to maintain a systolic BP Greater than 90mmHg) plus
one of the following: any requirement for pressors/inotropes prior to arrival at the
cath lab, clinical evidence of end organ hypoperfusion, lactate level greater than
2.5mmol/L

- Inferior STEMI or suspected right ventricular failure

- Suspected or known pregnancy

- Suspected active infection

- History or known hepatic insufficiency prior to catheterization

- On dialysis therapy

- Known contraindication to:

- Undergoing MRI or use of gadolinium

- Heparin, pork, pork products or contrast media

- Receiving a drug-eluting stent

- Participation in the active treatment or follow-up phase of another clinical study of
an investigational drug or device