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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Post-commercialization DCD New Enrollment Study

General
Study Status	Ongoing
Application Number / Requirement Number	P180051 S001/ PAS002
Date Original Protocol Accepted	04/27/2022
Date Current Protocol Accepted
Study Name	Post-commercialization DCD New Enrollment Study
Device Name	OCS Heart System
Clinical Trial Number(s)	NCT03831048   NCT04615182
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
Interim Results	Safety Results Graft survival @ 6 months: 97.6% (OCS DCD cohort) vs. 98.8% (SOC cohort) – Non-inferiority met. Effectiveness Results Patient survival @ 1 year: 91.6% (OCS DCD cohort) vs. 93.9% (SOC cohort) – Non-inferiority met.
Actual Number of Patients Enrolled	Primary Analysis Population: 167 (OCS DCD cohort) and 607 (Standard of Care [SOC] cohort: standard criteria donor hearts preserved using cold static cardioplegic storage)
Actual Number of Sites Enrolled	24
Patient Follow-up Rate	100%; no patients have been lost to follow-up in the OCS DCD cohort.

Post-commercialization DCD New Enrollment Study Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
6 month report	09/03/2022	08/31/2022	On Time
1 year report	03/03/2023	02/24/2023	On Time
18 month report	09/03/2023	08/28/2023	On Time
2 year report	09/03/2024	08/21/2024	On Time
analysis report	01/23/2025	01/23/2025	On Time
3 year report	09/03/2025
4 year report	09/03/2026
5 year report	09/03/2027
6 year report	09/03/2028
7 year report	09/03/2029
final report	09/03/2030

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