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

Status unconfirmed · Not applicable

Conditions studied: Right Heart Failure

In brief

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

Key facts

Study ID

NCT01777607

Run by

Abiomed Inc.

People needed

30

Starts

2013-05-01

Expected to finish

2016-06-01

Last updated by the study team

2013-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
• Albert Einstein Medical Center — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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