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

Abiomed Inc.1 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure

Interventions

Impella 2.5DEVICE

Impella 2.5 implant in patients with acute decompensated heart failure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Major Adverse Events

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.