Recruiting

Impella RP

Sponsor:

Abiomed Inc.

Code:

NCT01777607

Conditions

Right Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

IMPELLA® RP

Study Details

Brief summary:

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

Conditions

Right Heart Failure

Study ID

NCT01777607

Start date

May, 2013

Status verified date

May, 2013

Completion date

Jun, 2016

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Interventions

IMPELLA® RP

Primary outcome measure

  • Primary Benefit Endpoint [ Time Frame: 30 Days ]

Central Contacts and Locations

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Principal Investigator:

William O'Neill, MD

Albert Einstein Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Contacts

Principal Investigator:

Mark Anderson, MD

More Information

Sponsor

Abiomed Inc.

Last update posted

May 14, 2013

Last verified

May, 2013

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abiomed Inc. on 2013-05-14.