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

Right Heart Failure Clinical Trial

Official title:

The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01777607
• Other study ID #: Recover Right
• 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

• Heart Failure
• Right Heart Failure

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