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
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
Outcomes
Primary Outcome Measures
Major Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT01185691
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
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
We'll reach out to this number within 24 hrs