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

Abiomed Inc.2 sites in 1 country30 target enrollmentMay 2013

ConditionsRight Heart Failure

Overview

Phase: N/A
Intervention: Not specified
Conditions: Right Heart Failure
Sponsor: Abiomed Inc.
Enrollment: 30
Locations: 2
Primary Endpoint: Primary Benefit Endpoint
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2013

End Date

June 2016

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abiomed Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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
•Exclusion Criteria
•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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Primary Benefit Endpoint

Time Frame: 30 Days

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).