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

Sponsored by Abiomed Inc.

About this trial

Last updated 12 years ago

Study ID

Recover Right

Status

Unknown status

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 9 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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)