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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01185691

Acronym

RELIEF I

Enrollment

Registered

2010-08-20

Start date

2010-07-31

Completion date

2012-12-31

Last updated

2013-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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

Interventions

DEVICEImpella 2.5

Impella 2.5 implant in patients with acute decompensated heart failure

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Major Adverse Events	30 day or discharge(whichever is longer)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026