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

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ClinicalTrials.gov Identifier: NCT01777607
Recruitment Status : Unknown
Verified May 2013 by Abiomed Inc..
Recruitment status was:  Recruiting
First Posted : January 29, 2013
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.

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

Condition or disease Intervention/treatment Phase
Right Heart Failure Device: IMPELLA® RP Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study
Study Start Date : May 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention Device: IMPELLA® RP



Primary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777607


Locations
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox, RN    313-916-1879    mfox2@hfhs.org   
Principal Investigator: William O'Neill, MD         
United States, Pennsylvania
Albert Einstein Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19141
Contact: Maggie Flynn    267-421-7439    FlynnMag@einstein.edu   
Principal Investigator: Mark Anderson, MD         
Sponsors and Collaborators
Abiomed Inc.
Investigators
Principal Investigator: William O.Neill, MD Henry Ford Hospital
Principal Investigator: Mark Anderson, MD Albert Einstein Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT01777607     History of Changes
Other Study ID Numbers: Recover Right
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases