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Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients (RELIEF I)

Primary Purpose

Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Impella 2.5
Sponsored by
Abiomed Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Major Adverse Events

    Secondary Outcome Measures

    Full Information

    First Posted
    August 19, 2010
    Last Updated
    May 1, 2013
    Sponsor
    Abiomed Inc.
    Collaborators
    McGill University Health Centre/Research Institute of the McGill University Health Centre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01185691
    Brief Title
    Investigating the Role of Impella 2.5 System in Acutely Decompensated Chronic Heart Failure Patients
    Acronym
    RELIEF I
    Official Title
    RELIEF I: Investigating the Role of IMPELLA 2.5 System In Acutely Decompensated Chronic Heart Failure Patients. A Prospective, Single Center Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Terminated
    Why Stopped
    Low enrollment
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    December 2012 (Actual)
    Study Completion Date
    December 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Abiomed Inc.
    Collaborators
    McGill University Health Centre/Research Institute of the McGill University Health Centre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Impella 2.5
    Intervention Description
    Impella 2.5 implant in patients with acute decompensated heart failure
    Primary Outcome Measure Information:
    Title
    Major Adverse Events
    Time Frame
    30 day or discharge(whichever is longer)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Major 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 Major 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Renzo Cecere, MD
    Organizational Affiliation
    McGill University Health Centre/Research Institute of the McGill University Health Centre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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