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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Abiomed Inc.
Sponsor:
Information provided by (Responsible Party):
Abiomed Inc.
ClinicalTrials.gov Identifier:
NCT01777607
First received: January 25, 2013
Last updated: May 11, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Right Heart Failure
Device: IMPELLA® RP

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Abiomed Inc.:

Primary Outcome Measures:
  • Primary Benefit Endpoint [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 30
Study Start Date: May 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intervention Device: IMPELLA® RP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Abiomed Inc.
ClinicalTrials.gov Identifier: NCT01777607     History of Changes
Other Study ID Numbers: Recover Right
Study First Received: January 25, 2013
Last Updated: May 11, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014