Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients

RELIEF I: Investigating the Role of IMPELLA 2.5 System In Acutely Decompensated Chronic Heart Failure Patients. A Prospective, Single Center Feasibility Study

The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in Acute Decompensated Heart Failure patients.

Major Inclusion Criteria:

1. Chronic heart failure patients, hospitalized due to decompensated heart failure (ADHF) with NYHA Class III-IV symptoms (ADHF is defined by the presence of at least one of the following symptoms/signs: dyspnea w/orthopnea, jugular venous distension, peripheral edema +2, abdominal ascites, signs of CHF on chest X-Ray)
2. LVEF ≤ 40 % within the past 3 months

Major Exclusion Criteria:

1. Acute Q-wave myocardial infarction or Acute coronary syndrome within past 30 days
2. Cardiac surgery within the past 30 days
3. Implantation of cardiac resynchronization device within past 30 days or a possibility of implanting a biventricular pacer within 90 days of randomization