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

• Sponsor: Abiomed Inc. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT01777607
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arm: 1
• Duration (Months): 37
• Patients Per Site: 15
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Right Heart Failure	Device: IMPELLA® RP	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study
• Study Start Date: May 1, 2013
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention	Device: IMPELLA® RP

Outcome Measures

Primary Outcome Measures

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henry Ford Hospital	Detroit	Michigan	United States	48202
2	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141

Sponsors and Collaborators

• Abiomed Inc.

Investigators

• Principal Investigator: William O.Neill, MD, Henry Ford Hospital
• Principal Investigator: Mark Anderson, MD, Albert Einstein Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abiomed Inc.
• ClinicalTrials.gov Identifier: NCT01777607
• Other Study ID Numbers: Recover Right
• First Posted: Jan 29, 2013
• Last Update Posted: May 14, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of May 14, 2013