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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 12/18/2020
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 primary and secondary endpoints have been met in comparison to performance goals
derived from clinical study outcomes for devices indicated fro ASD clsure.
Actual Number of Patients Enrolled 613
Actual Number of Sites Enrolled 22
Patient Follow-up Rate 30 day visit: 97.3%; Month 6 Visit: 95.1%; Month 12 Visit: 90.1%; Month 24 Visit: 85.8%; Month
36 Visit: 75.4%
Final Safety Findings ¿ Of the 613 evaluable subjects, 25 subjects experienced one or more SAEs within 30 days post-index
procedure.
¿ 49 subjects reported a total of 77 SAEs, 31 SAEs are device-related, 7 SAEs are procedure-related.
¿ 371 subjects (60.5%) reported at least one MedDRA-coded AE.
Final Effect Findings Of the 566 subjects with technical success, 516 completed 6-month clinical residual defect
check, 100% (516/516) achieved 6-month clinical closure success
¿ Of the 577 subjects who have completed 6-month composite clinical success evaluation, 503
(87.2%) achieved Composite Clinical Success, 74 (12.8%) experienced clinical Failure at 6-month
post-procedure
¿ Technical and procedure success rates were both 92.3%
Study Strengths & Weaknesses This study follows up the IDE and Continued Access cohorts through three years post-procedure
and provides longer term safety and effectiveness results of the GORE CARDIOFORM ASD
Occluder device.


Continued F/u of the ASSURED Study Schedule

Report 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
4 year 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

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