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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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 Premarket Pivotal Cohort


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General
Study Status Study Pending
Application Number P160054 S008/ PAS001
Date Current Protocol Accepted  
Study Name Continued f/u of Premarket Pivotal Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To characterize the clinical outcomes through 5 years post implantation by continuing to follow the premarket pivotal cohort of patients.
Study Population Description Subjects (both HeartMate 3 and HeartMate II) who were enrolled in the premarket pivotal cohort.
Sample Size All living subjects (about 533).
Data Collection 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 5 years


Continued f/u of Premarket Pivotal Cohort Schedule

Report 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    
three year report 10/17/2021    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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