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Clinical Trials/NCT01185691
NCT01185691
Terminated
N/A

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

Abiomed Inc.0 sites1 target enrollmentJuly 2010
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ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Abiomed Inc.
Enrollment
1
Primary Endpoint
Major Adverse Events
Status
Terminated
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 2010
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Major Adverse Events

Time Frame: 30 day or discharge(whichever is longer)

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