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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01777607
Other study ID # Recover Right
Secondary ID
Status Recruiting
Phase N/A
First received January 25, 2013
Last updated May 11, 2013
Start date May 2013
Est. completion date June 2016

Study information

Verified date May 2013
Source Abiomed Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2016
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
IMPELLA® RP


Locations

Country Name City State
United States Henry Ford Hospital Detroit Michigan
United States Albert Einstein Medical Center Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Abiomed Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Benefit Endpoint 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). 30 Days No
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