|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140003 S005/ PAS001 |
| Date Original Protocol Accepted |
08/09/2016
|
| Date Current Protocol Accepted |
07/13/2021
|
| Study Name |
Impella PCCS PAS
|
| Device Name |
IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the study is to evaluate the safety and effectiveness of Impella devices in a real world representative population through the cVAD registry.
The study design is an observation, prospective and retrospective, multicenter, and single cohort clinical investigation of patients who suffered cardiogenic shock after open heart surgery and received an Impella device.
|
| Study Population |
Patients (>18 years old) supported with Impella devices (Impella 2.5, CP, 5.0 or LD) for the indication of post-cardiotomy
cardiogenic shock (PCCS), enrolled in the cVAD registry at U.S. institutions, after the PMA post market study approval will be considered eligible for the post-approval study. Patients will be enrolled consecutively without interruption at all participating sites without preselection.
|
| Sample Size |
A minimum of 44 participants will be evaluated to compare the survival rate at 30 days or discharge, whichever is longer, to a performance goal of 30%. It is estimated that 48 participants will be enrolled, assuming 10% loss to follow-up to 30 days post- procedure.
|
| Key Study Endpoints |
Primary endpoint:
Survival rate at 30 days or discharge, whichever is longer.
Secondary endpoints:
Adverse event rates at 30 days or discharge whichever is longer. The technical success rate and device (implant) success rate at exit from catheterization laboratory or operation room.
|
| Follow-up Visits and Length of Follow-up |
1 year post implant
30 days, 90 days, 1 year post implant
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
63
|
| Actual Number of Sites Enrolled |
46
|
| Patient Follow-up Rate |
83%
|
| Final Safety Findings |
Secondary endpoints for the study conducted covers both adverse event rates within the time frame of the primary endpoint and technical/ device success rates. The device and technical success rates exceeded 98% which demonstrates that the device can be safely implanted and positioned for hemodynamic support. A few adverse events such as bleeding, infection and thrombocytopenia, occurred at a higher incidence when compared to the rates of the same events specifically related to the Impella procedure and device.
|
| Final Effect Findings |
The primary endpoint of survival at 30 days post-implant or discharge, whichever is longer, was found to be 55.0 % (33/60). This fulfilled the PAS requirement for a 30% survival rate.
|
| Study Strengths & Weaknesses |
The study was able to effectively fill the requirements for the PAS with respect to the primary endpoint, patient outcomes at 30 days post-implant or discharge, whichever comes first. However, the contributory role of patient profile, comorbidities, and nature of surgery remains open as the study was not designed to answer such questions due to the limited subject population.
|
| Recommendations for Labeling Changes |
Yes
|
