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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Right Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Group Type EXPERIMENTAL

IMPELLA® RP

Intervention Type DEVICE

Interventions

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IMPELLA® RP

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No