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

Not Applicable

Terminated

• Conditions: Heart Failure

• Registration Number: NCT01185691
• Lead Sponsor: Abiomed Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-19
• Study First Submitted QC: 2010-08-19
• Study First Posted: 2010-08-20
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-01
• Last Update Posted: 2013-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major Adverse Events	30 day or discharge(whichever is longer)