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

Not Applicable

• Conditions: Right Heart Failure
• Interventions: Device: IMPELLA® RP

• Registration Number: NCT01777607
• Lead Sponsor: Abiomed Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-25
• Study First Submitted QC: 2013-01-25
• Study First Posted: 2013-01-29
• Status Verified: 2013-05
• Study Start: 2013-05
• Last Update Submitted: 2013-05-11
• Last Update Posted: 2013-05-14
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	IMPELLA® RP	-

Primary Outcome Measures

Name	Time	Method
Primary Benefit Endpoint	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).

Trial Locations

Locations (2)

Albert Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States