Right Heart Failure
Conditions
Brief summary
The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.
Interventions
DEVICEIMPELLA® RP
Sponsors
Abiomed Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed