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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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Continued F/u of the ASSURED Study


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General
Study Status Progress Adequate
Application Number P050006 S071/ PAS001
Date Current Protocol Accepted  
Study Name Continued F/u of the ASSURED Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Neonate: 1-28 days, Infant: 29 days-2 yrs, Child: 2-12 yrs, Adolescent: 13-18 yrs, Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description To characterize the clinical outcomes annually through 3 years post-procedure of all living subjects who were enrolled during the IDE pivotal and continued-access phases of the ASSURED study.
Study Population Description All living subjects who were enrolled during the pivotal and continued-access phases of the ASSURED study.
Sample Size All living subjects who were enrolled during the pivotal and continued-access phases of the ASSURED study.
Data Collection Closure Success

Composite Clinical Success, including: 1) Technical Success, 2) Safety Success 3) Closure Success

Freedom from serious adverse events

Freedom from device events (embolization, device removal, or other device intervention)

• Clinically Significant New Arrhythmia

Follow-up Visits and Length of Follow-up Total of 3 years post-procedure.
Interim or Final Data Summary
Interim Safety Information Both safety and effectiveness endpoints results appear to be comparable to those from the IDE phase

Actual Number of Patients Enrolled 613
Actual Number of Sites Enrolled 22
Patient Follow-up Rate 30 day visit: 96.4%; Month 6 Visit: 92.8%; Month 12 Visit: 74.8%; Month 24 Visit: 65.3%; Month 36 Visit: 16.7%
Study Strengths & Weaknesses Strength: endpoint results consistent with those from the IDE phase

Weaknesses: relatively large number of missed endpoint evaluations


Continued F/u of the ASSURED Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 05/27/2020 05/29/2020 Overdue/Received
two year report 05/27/2021 05/26/2021 On Time
three year report 05/27/2022    
four yea report 05/27/2023    


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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