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



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:4/2/2016
Start Date:May 2013
End Date:June 2016

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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.


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)
We found this trial at
2
sites
2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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5501 Old York Road
Philadelphia, Pennsylvania 19141
215-456-7890
Albert Einstein Medical Center Einstein Healthcare Network is a private, not-for-profit organization with several major...
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Philadelphia, PA
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