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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Impella PCCS PAS


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General
Study Status Progress Adequate
Application Number P140003 S005/ PAS001
Date Current Protocol Accepted 08/09/2016
Study Name OSB Lead-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, 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


OSB Lead-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    
three year report 04/07/2019    
four year report 04/06/2020    
five year report 04/06/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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