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

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01185691
• Other study ID #: 09-248-SDR
• Status: Terminated
• Phase: N/A
• First received: August 19, 2010
• Last updated: May 1, 2013
• Start date: July 2010
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Abiomed Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Impella 2.5
Impella 2.5 implant in patients with acute decompensated heart failure

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abiomed Inc.	McGill University Health Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Events		30 day or discharge(whichever is longer)	Yes