The Use of Impella RP Support System in Patients With Right Heart Failure

May 11, 2013 updated by: Abiomed Inc.

The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study

The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Recruiting
        • Albert Einstein Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
  2. Age ≥18 years old
  3. Signed Informed consent

Exclusion Criteria

  1. INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
  2. Evidence of acute neurologic injury
  3. RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
  4. Intolerance to anticoagulant or antiplatelet therapies
  5. Existing congenital heart disease that would preclude the insertion of the device.
  6. Participation in any other clinical investigation that is likely to confound study results or affect study outcome
  7. Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Device: IMPELLA® RP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Benefit Endpoint
Time Frame: 30 Days
Survival at 30 days or hospital discharge whichever is longer post device explant or to the next therapy, including transplant, bridge to transplant or destination therapy with FDA approved surgical VAD (Ventricular Assit Device).
30 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abiomed Inc.

Investigators

  • Principal Investigator: William O.Neill, MD, Henry Ford Hospital
  • Principal Investigator: Mark Anderson, MD, Albert Einstein Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

June 1, 2016

Study Registration Dates

First Submitted

January 25, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (ESTIMATE)

January 29, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 11, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Recover Right

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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