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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Continued f/u of Continued Access Cohort


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General
Study Status Completed
Application Number /
Requirement Number		 P160054 S008/ PAS002
Date Original Protocol Accepted 01/18/2019
Date Current Protocol Accepted  
Study Name Continued f/u of Continued Access Cohort
Device Name HeartMate 3 Left Ventricular Assist System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives To characterize the clinical outcomes through 2 years post implantation by continuing to follow the premarket continued access protocol (CAP) patients.
Study Population Subjects (HeartMate 3 only) who were enrolled in the premarket CAP cohort.
Sample Size All living subjects
Key Study Endpoints The composite endpoint of survival to transplant or recovery, or
on left ventricular assist device (LVAD) support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump; mortality; bleeding; major infection; hemolysis; device thrombosis; neurological dysfunction; and any other serious adverse events; as well as New York Heart Association (NYHA) classification and 6-minute walk distance (6MWD).
Follow-up Visits and Length of Follow-up 2 years
Interim or Final Data Summary
Actual Number of Patients Enrolled 1685
Actual Number of Sites Enrolled 68
Patient Follow-up Rate 98.3%
Final Safety Findings The rates of adverse events at 2 years were largely similar between the CAP and Pivotal Cohorts.
Final Effect Findings The survival rate, functional status and quality of life improvements in the CAP Cohort were also comparable to those observed in the Pivotal Cohort at 2 years.
Study Strengths & Weaknesses The study’s main strength was its size in patient cohort, which was more than 3 times greater than the treatment arm of the pivotal cohort. The study’s main weakness was that it was a non-randomized study with inherent biases.
Recommendations for Labeling Changes Yes


Continued f/u of Continued Access Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 10/18/2019 10/17/2019 On Time
two year report 10/17/2020 10/15/2020 On Time
final report 10/17/2021 06/29/2021 On Time


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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