|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140003 S004/ PAS001 |
| Date Original Protocol Accepted |
08/09/2016
|
| Date Current Protocol Accepted |
07/13/2021
|
| Study Name |
Impella AMI CS PAS
|
| Device Name |
IMPELLA VENTRICULAR SUPPORT SYSTEMS
|
| 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 supported with Impella devices for the indication of AMICS with revascularization and enrolled in the cVAD registry.
|
| Study Population |
Patients (> 18 years old) supported with Impella devices (Impella
2.5, CP, 5.0 or LD) for the indication of acute myocardial infarction (AMICS) with revascularization and 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 276 participants will be evaluated to compare the survival rate at 30 days or discharge, whichever is longer, to a performance goal of 34%. It is estimated that 304 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 to 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 follow ups
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
418
|
| Actual Number of Sites Enrolled |
41
|
| Patient Follow-up Rate |
68%
|
| Final Safety Findings |
The relatively more frequent site-reported adverse events at 30 days or discharge, whichever is longer, included: death (48.8%), anemia requiring transfusion (25.60%), acute renal dysfunction/failure (22.97%), hypotension during support (20.10%), cardiac arrest (17.94%), and ventricular arrhythmia (15.07%).
|
| Final Effect Findings |
In evaluable patients (i.e., those with a known status for the primary endpoint), the PAS’ primary endpoint of survival at 30 days or discharge, whichever is longer, met the prespecified performance goal of 34%. However, in the sensitivity analysis for the worst-case scenario where all patients without a known status for the primary endpoint were assumed to have died, the PAS missed the performance goal. The survival rates at 30 days and at discharge were generally consistent with the premarket results.
|
| Study Strengths & Weaknesses |
The study’s main strength was its representation of the real-world experience and its size in patient cohort, which was much bigger than the main clinical data set used to support the PMA approval. The study’s main weakness was its relatively low follow-up rate due to some participating sites not being able to obtain post-discharge follow-up consent from all enrolled subjects.
|
| Recommendations for Labeling Changes |
Yes
|
