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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 FU of the DCD Heart Premarket Cohort


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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
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 Patient survival: 86.8% at 2 years (pivotal DCD); 83.7% at 2 years (pivotal SOC); 92.1% at 1 year (CAP DCD)
Cardiac-related patient survival: 96.1% at 2 years (pivotal DCD); 97.0% at 2 years (pivotal SOC); 97.8% at 1 year (CAP DCD)
Graft survival 97.7% at 2 years (pivotal DCD); 96.7% at 2 years (pivotal SOC); 95.6% at 1 year (CAP DCD)
Patient and graft survival: 86.8% at 2 years (pivotal DCD); 81.8% at 2 years (pivotal SOC); 90.0% at 1 year (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: 99.4% at 2 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
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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