f Post-Approval Studies (PAS) Database
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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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Post-commercialization DBD New Enrollment Study


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General
Study Status Ongoing
Application Number /
Requirement Number		 P180051 / PAS002
Date Original Protocol Accepted 09/03/2021
Date Current Protocol Accepted  
Study Name Post-commercialization DBD New Enrollment Study
Device Name Organ Care System (OCS) Heart System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This is a prospective, multi-center, single-arm new enrollment study. The objective of the study is to characterize the performance of the OCS Heart System in the real-world setting, as compared to concurrent control data obtained from the United Network for Organ Sharing (UNOS) database for recipients of standard criteria donor hearts preserved using cold static cardioplegic storage.
Study Population Patients needing heart transplant
Sample Size 150 patients that constitute the Primary Analysis Population
Key Study Endpoints The primary endpoint is patient survival at 1 year post-transplant. Other endpoints include patient/graft survival through 5 years posttransplant, incidence of moderate or severe primary graft dysfunction (PGD; left or right ventricle), and incidence of donor heart turndowns following OCS Heart System perfusion.
Follow-up Visits and Length of Follow-up 5 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 182 (Primary Analysis Population)
Actual Number of Sites Enrolled 24
Patient Follow-up Rate 100%; no patients have been lost to follow up.
Final Safety Findings Graft survival: @ 30 days: 181/182 (99.5%)
Final Effect Findings Patient survival @ 30 days: 174/182 (95.6%)


Post-commercialization DBD New Enrollment Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/04/2022 03/02/2022 On Time
1 year report 09/03/2022 08/31/2022 On Time
18 month report 03/04/2023 02/24/2023 On Time
2 year report 09/03/2023 08/28/2023 On Time
30 month report 03/04/2024 02/27/2024 On Time
3 year report 09/02/2024    


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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