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 f/u of Continued Access Cohort

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
Clinical Trial Number(s)	NCT02224755
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
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

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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