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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Impella PCCS PAS


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General
Study Status Completed
Application Number P140003 S005/ PAS001
Date Current Protocol Accepted 07/13/2021
Study Name Impella PCCS PAS
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 Design Description 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 Description 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.
Data Collection 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


Impella PCCS PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/06/2016 10/07/2016 Overdue/Received
one year report 04/07/2017 04/07/2017 On Time
18 month report 10/06/2017 10/10/2017 Overdue/Received
two year report 04/07/2018 04/03/2018 On Time
three year report 05/07/2019 05/07/2019 On Time
four year report 04/06/2020 04/06/2020 On Time
five year report 04/06/2021 04/05/2021 On Time
final report 11/05/2021 11/05/2021 On Time


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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