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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P170011 / PAS002 |
| Date Original Protocol Accepted |
09/20/2017
|
| Date Current Protocol Accepted |
02/16/2018
|
| Study Name |
Impella RP Pediatric-RWE Eval and Report
|
| Device Name |
Impella RP System
|
| Clinical Trial Number(s) |
NCT01777607
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adolescent: 13-18 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
To monitor post-market approval safety and outcomes trends of the Impella RP device in pediatric patients with RV failure deemed to require hemodynamic support.
A single-arm multicenter registry study of patients from the premarket (i.e. the HDE Impella RP Pediatric Study) and newly treated patients after PMA approval. All data will be collected retrospectively after implant.
|
| Study Population |
Pediatric patients aged 15-17 years old (BSA greater than or equal to 1.5m2) with right heart failure supported with the Impella RP System. Patients who meet all eligibility criteria.
There is no comparison group.
|
| Sample Size |
Fifteen (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 |
The primary endpoint is survival rate at 30 days post device explant or hospital discharge (whichever is longer), or to induction of anesthesia to a longer term therapy, which includes a heart transplant or an implant of a surgical RVAD.
Secondary safety endpoints are the 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 death and cardiac), major bleeding, hemolysis, pulmonary embolism.
Additional adverse events to be collected are device malfunction and device failure.
Secondary effectiveness endpoints are improvement in the following hemodynamic parameters after Impella RP support through explant: cardiac index, central venous pressure, LVAD flow
Technical success will be assessed at exit from operating room
Survival only will be assessed at 30 days and 180 days.
|
| Follow-up Visits and Length of Follow-up |
180 days
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
One (1) patient with a protocol deviation in age cutoff treated at a non-participating site
|
| Actual Number of Sites Enrolled |
One (1) non-participating site
|
| Patient Follow-up Rate |
The one patient was captured in the firm’s commercial database, which contains limited data entered by the firm’s field clinical personnel and only covers the time period from Impella device insertion through Impella device removal. The patient was known to have survived to induction of anesthesia to a longer-term therapy.
|
| Final Safety Findings |
No adverse events (death, major bleeding, hemolysis, and pulmonary embolism) were reported for the patient, to induction of anesthesia to a longer-term therapy.
|
| Final Effect Findings |
The patient survived to induction of anesthesia to a longer term therapy (surgical RVAD). The patient’s central venous pressure (CVP) decreased from 28 mmHg to 19 mmHg on Impella RP support.
|
| Study Strengths & Weaknesses |
The study was limited by the low enrollment (N=1) and limited dataset available.
|
| Recommendations for Labeling Changes |
Yes
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