|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
H140001 / PAS002 |
Date Original Protocol Accepted |
01/23/2015
|
Date Current Protocol Accepted |
01/23/2015
|
Study Name |
Impella RP Pediatric Study
|
Device Name |
IMPELLA RP SYSTEM
|
General Study Protocol Parameters |
Study Design |
Retrospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
No Control
|
Analysis Type |
Descriptive
|
Study Population |
Adolescent: 13-18 yrs
|
Detailed Study Protocol Parameters |
Study Objectives |
A retrospective, single-arm multicenter study
|
Study Population |
Pediatric patients with the right side heart failure supported with the Impella RP System.
Patients that meet all eligibility criteria
|
Sample Size |
15 consecutive pediatric patients or all pediatric patients supported with the Impella RP over a 5 year time period (whichever comes first) will be enrolled at a minimum of 5 participating clinical centers.
|
Key Study Endpoints |
Data collected in the PAS will be based on institutional standard of care. Data will be retrospectively collected throughout the study. Data must be collected on the case report forms. Source documents include, but are not limited to, death certificate, autopsy report, laboratory reports, operative report, echocardiograms, ultrasound report, angiograms, cardiac catheterization logs and cardiac catheterization reports, patient discharge report. Primary: Survival at 30 days post device explant or hospital discharge (whichever is longer), or to induction of anesthesia to a longer term therapy, including a heart transplant or an implant of a surgical RVAD.
Secondary: Safety Rates of the following major adverse events measured at hospital discharge or to induction of anesthesia to a longer term therapy (including a heart transplant or an implant of a surgical RVAD): Death (any cause of death and cardiac death) Major Bleeding Hemolysis Pulmonary Embolism
Survival only will be assessed at 30 days (± 10 days) and 180 days (± 30 days).
Other adverse events Device failures and malfunctions will be retrospectively documented
Secondary Probable benefit Improvement in hemodynamic parameters Cardiac Index Central Venous Pressure LVAD flows after initiation of Impella RP support.
Major adverse events will be reviewed adjudicated and categorized by the Clinical Events Committee.
|
Follow-up Visits and Length of Follow-up |
180 days post explant Survival status will be assessed at 30 and 180 days post explant
|