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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Study Status Progress Inadequate
Application Number /
Requirement Number
P100047 S090/ PAS002
Date Original Protocol Accepted 07/26/2018
Date Current Protocol Accepted 02/12/2021
Device Name HeartWare™ HVAD™ System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The objective of the study is to estimate patient survival free of death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation following HeartWare Ventricular Assist Device (HVAD) implantation for destination therapy (DT).
This post-approval study (PAS) is a prospective, observational, multi-site study conducted through Medtronic’s Product Surveillance Registry (PSR).
Study Population Patients using the HVAD system as destination therapy.
Sample Size The PAS cohort will be comprised of 300 newly enrolled patients. This sample size will estimate the primary endpoint rate at 24 months post-original implant within 6.0%. The following assumptions were used:
- Two-sided 95% confidence intervals will be computed
- Goal is to estimate the primary objective survival rate at 2 years
- Survival rate at 24 months is 59.2%, which is based on the Endurance Supplemental HeartWare success rate using data through March 27, 2017 (data pull May 30, 2017).
- Attrition will be 10% from implant to 24 months, primarily consisting of transplants
Approximately 50 sites will participate in the PAS.
Key Study Endpoints The primary endpoint/objective is survival free of disabling stroke or device malfunction requiring exchange, explant, or urgent transplant.
Secondary endpoints:
- Observed early stroke rate (stroke occurring =2 years post-implant), and stroke risk factors.
- Late stroke rate (stroke occurring >2 years post-implant) and to evaluate risk factors for late stroke.
- Stroke severity for all subjects who experience a stroke on device while in this study. Stroke severity will be assessed through modified Rankin Scale (mRS) scoring.
Additional endpoints:
Effectiveness of Invasive Blood Pressure Monitoring (IBPM), a summary of neurologic dysfunction events (ischemic cerebrovascular accidents, hemorrhagic cerebrovascular accidents, and transient ischemic attacks), overall survival on device, INTERMACS adverse event rates, quality of life measures (measured by EuroQol EQ-5D-DL and Kansas City Cardiomyopathy Questionnaire), and functional status (measured by the 6-minute walk test).
Follow-up Visits and Length of Follow-up Subjects will be followed through five years post-implant
Interim or Final Data Summary
Interim Results Freedom from stroke through six-months is approximately 83%, and through 12-months is approximately 72%. Overall survival on HVAD through six-months is approximately 80%, and through 12-months is approximately 69%.
Actual Number of Patients Enrolled 277
Actual Number of Sites Enrolled 43
Patient Follow-up Rate 273 patients have been evaluated at discharge, 230 patients have been evaluated at the 3-month follow-up visit, 201 patients have been evaluated at the 6-month follow-up visit, 149 patients have been evaluated at the 12-month visit, and 10 patients have been evaluated at the 18-month visit.
Study Strengths & Weaknesses Follow-up rate is fairly high for all visits except the 18-month and 24-month visits. However, the completion rate for several important measures, including the modified Rankin Scale scores an assessment of stroke severity, are very low. This means interpretation of the available results may not reflect the experience of all study participants.

ENDURANCE PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 03/28/2018 04/25/2018 Overdue/Received
one year report 09/27/2018 09/12/2018 On Time
18 month report 03/28/2019 03/28/2019 On Time
two year report 09/27/2019 09/30/2019 Overdue/Received
30 month report 03/27/2020 03/30/2020 Overdue/Received
three year report 09/26/2020 09/24/2020 On Time
42 month report 03/27/2021 03/26/2021 On Time
4 year report 10/26/2021 10/15/2021 On Time
5 year report 09/27/2022 09/21/2022 On Time
6 year report 09/27/2023    

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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