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

This study is currently recruiting participants.

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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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

Criteria

Inclusion Criteria:

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).
Age ≥18 years old
Signed Informed consent

Exclusion Criteria

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)
Evidence of acute neurologic injury
RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
Intolerance to anticoagulant or antiplatelet therapies
Existing congenital heart disease that would preclude the insertion of the device.
Participation in any other clinical investigation that is likely to confound study results or affect study outcome
Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)

Contacts and Locations

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 June 18, 2013