Status:
TERMINATED
Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients
Lead Sponsor:
Abiomed Inc.
Collaborating Sponsors:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Heart Failure
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The primary objective of this study is to assess safety and feasibility of IMPELLA 2.5 in Acute Decompensated Heart Failure patients.
Eligibility Criteria
Inclusion
- Major
- 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)
- LVEF ≤ 40 % within the past 3 months
- Major
Exclusion
- Acute Q-wave myocardial infarction or Acute coronary syndrome within past 30 days
- Cardiac surgery within the past 30 days
- Implantation of cardiac resynchronization device within past 30 days or a possibility of implanting a biventricular pacer within 90 days of randomization
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01185691
Start Date
July 1 2010
End Date
December 1 2012
Last Update
May 3 2013
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