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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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OCS Heart EXPAND+CAP Continued f/u PAS


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General
Study Status Ongoing
Application Number /
Requirement Number		 P180051 / PAS001
Date Original Protocol Accepted 09/03/2021
Date Current Protocol Accepted  
Study Name OCS Heart EXPAND+CAP Continued f/u PAS
Device Name Organ Care System (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 G140111, 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 G140111, 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
Actual Number of Patients Enrolled 75 in the pivotal cohort and 75 in the CAP cohort
Actual Number of Sites Enrolled 9
Patient Follow-up Rate Pivotal: 92% at 5 years (all patients have reached 5 years)
CAP: 100% at 1 year (all patients have reached 1 year)
Final Safety Findings See effectiveness results.
Final Effect Findings Patient survival: 76.1% at 5 years (pivotal); 94.7% at 1 year (CAP)
Cardiac-related patient survival: 94.6% at 5 years (pivotal); 100% at 1 year (CAP)
Graft survival: 93.1% at 5 years (pivotal); 98.6% at 1 year (CAP)


OCS Heart EXPAND+CAP Continued f/u PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/03/2022 08/16/2022 On Time
2 year report 09/03/2023 08/15/2023 On Time
3 year report 09/03/2024    


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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