Post-Approval Studies (PAS) Database

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

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: Birth < 29 days, Infant: 29 days < 2 yrs, Child: 2 yrs < 12 yrs, Adolescent: 13-18 yrs, Transit.Adolescent A (distinctively):18 yrs<22 yrs, Transit.Adolescent B(as adults): 18 yrs < 22 yrs, Adult: At least 22 yrs
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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background