The Use of Impella RP Support System in Patients With Right Heart Failure
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ClinicalTrials.gov Identifier: NCT01777607
Verified May 2013 by Abiomed Inc.. Recruitment status was: Recruiting
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:
Accepts Healthy Volunteers:
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
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