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 FU of the DCD Heart Premarket Cohort

General
Study Status	Ongoing
Application Number / Requirement Number	P180051 S001/ PAS001
Date Original Protocol Accepted	04/27/2022
Date Current Protocol Accepted
Study Name	Continued FU of the DCD Heart Premarket Cohort
Device Name	OCS Heart System
Clinical Trial Number(s)	NCT03831048   NCT04615182
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
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	Continued follow-up of all living subjects enrolled under IDE G180272, including the Continued Access Protocol subjects. The objective of this study is to characterize the clinical outcomes of these subjects annually through 5 years post-transplant.
Study Population	All living subjects enrolled under IDE G180272, including the Continued Access Protocol subjects.
Sample Size	All living subjects
Key Study Endpoints	patient survival, cardiac-related patient survival, and heart graft survival through 5 years post-transplan.
Follow-up Visits and Length of Follow-up	5 years
Interim or Final Data Summary
Interim Results	Safety Results: see effectiveness results Effectiveness Results: Patient survival: 83.1%% at 3 years (pivotal DCD); 76.3%% at 3 years (pivotal SOC); 84.8% at 2 years (CAP DCD) Cardiac-related patient survival: 96.5% at 3 years (pivotal DCD); 97.5% at 3 years (pivotal SOC); 96.4% at 2 years (CAP DCD) Graft survival 96.2% at 3 years (pivotal DCD); 96.7% at 3 years (pivotal SOC); 94.3% at 2 years (CAP DCD) Patient and graft survival: 81.8% at 3 years (pivotal DCD); 74.6% at 3 years (pivotal SOC); 81.8% at 2 years (CAP DCD)
Actual Number of Patients Enrolled	270 (including 90 DCD patients and 90 SOC patients in the pivotal trial as well as 90 DCD patients in the CAP investigation)
Actual Number of Sites Enrolled	20
Patient Follow-up Rate	Pivotal: 98.9% at 3 years CAP: 100% at 1 year

Continued FU of the DCD Heart Premarket Cohort Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	05/03/2023	04/26/2023	On Time
2 year report	05/03/2024	04/24/2024	On Time
3 year report	05/03/2025
4 year report	05/03/2026
final report	09/03/2026

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