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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 Completed
Application Number /
Requirement Number		 P050006 S071/ PAS001
Date Original Protocol Accepted 05/28/2019
Date Current Protocol Accepted 12/18/2020
Study Name Continued F/u of the ASSURED Study
Device Name GORE Cardioform ASD Occluder
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 Objectives 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 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.
Key Study Endpoints 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
Actual Number of Patients Enrolled 613
Actual Number of Sites Enrolled 22
Patient Follow-up Rate 1m – 98.4%
6m – 96.4%
12m – 94.6%
24m – 90.4%
36m – 77.7%
Final Safety Findings 379 subjects (61.8%) reported 1 MedDRA-coded AE; a total 52 subjects reported 82 SAEs; 31 SAEs were device-related, 7 SAEs were procedure-related; 26 subjects reported SAE within 30 days of index procedure.
Final Effect Findings 516 of the 566 subjects with technical success completed 6-month clinical residual defect check, and 1000% (516/516) achieved 6-month clinical closure success. 503 of the 577 subjects evaluated for 6-month composite clinical success achieved composited clinical success (87.2%); 74 (12.8%) experienced clinical failure at 6-month post procedure. Technical and procedure success rates were both 92.3%.
Study Strengths & Weaknesses Study strengths: Additional enrollment into the Continued Access cohort and long-term follow-up through 3 years post-procedure.
Weaknesses: The rate for the 36-month fluoroscopy follow-up was low at only 33.4%
Recommendations for Labeling Changes Yes


Continued F/u of the ASSURED Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 05/27/2020 05/29/2020 Overdue/Received
2 year report 05/27/2021 05/26/2021 On Time
3 year report 05/27/2022 05/31/2022 Overdue/Received
final report 05/27/2023 04/19/2023 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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