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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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Cont F/u of HW004-A ENDURANCE

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Study Status Completed
Application Number /
Requirement Number
P100047 S090/ PAS001
Date Original Protocol Accepted 03/15/2018
Date Current Protocol Accepted 08/06/2018
Study Name Cont F/u of HW004-A ENDURANCE
Device Name HeartWare™ HVAD™ System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives This study was designed to evaluate longer-term safety and effectiveness outcomes of patients receiving an HVAD for Destination Therapy through continued follow-up of all living subjects who were enrolled in the ENDURANCE Supplemental trial under G090243.
Study Population All subjects who were enrolled in the ENDURANCE Supplemental trial and alive at 12 months post-original implant.
Sample Size All subjects who were alive at 12 months post-original implant are eligible for continued follow-up.
Key Study Endpoints Subjects will be followed out to five years post-original implant and descriptive data will be collected in accordance with the protocol.
Follow-up Visits and Length of Follow-up 5 years post-original implant procedure
Interim or Final Data Summary
Actual Number of Patients Enrolled 494 subjects were enrolled, of which 475 were randomized and 465 (HVAD n=308, Control n=157) were implanted.
Actual Number of Sites Enrolled 50 sites were activated for enrollment. Of these, 48 sites enrolled a subject into the trial.
Patient Follow-up Rate 95% Follow-up for HVAD and 98% Follow-up for Control
Final Safety Findings For both the HVAD and Control groups, the most common Intermacs adverse events by event rate at 60 months were, by decreasing order: infections (76.3% HVAD, 75.8% Control), bleeding (66.6% HVAD, 68.2% Control), device malfunction/failure (44.8% HVAD, 40.8% Control), and cardiac arrythmia (41.9% HVAD, 42.0% Control).

Neurological Adverse Events: The overall stroke rate at 60 months was 26.3% for HVAD and 23.6% for Control. The overall incidence of ICVA was 17.9% for HVAD and 13.4% for Control. The overall incidence of HCVA was 12.0% for HVAD and 12.7% for Control. The overall incidence of TIA was 10.4% for HVAD and 5.1% for Control. Of the total deaths that occurred in the study for each group, 25 HVAD patients (15.3%) and 15 Control patients (17.6%) had their CEC adjudicated cause of death attributed to stroke.

Device Malfunction: There were a total of 138 (44.8%) HVAD and 64 (40.8%) Control subjects who experienced a device failure/malfunction during the study. The most common event in both arms was pump thrombosis (51.4% HVAD, 56.3% Control). Freedom from thrombus on the original device at 60 months was 62.2% for HVAD and 68.7% for Control. The second most common event in both arms was Controller Fault (33.3% HVAD, 31.3% Control).

Device Exchange: For the HVAD subjects, there were 54 pump exchanges in 45 subjects (14.6%), compared to 37 pump exchanges in 28 Control subjects (17.8%).The most common reason for device exchange was Device Thrombosis (including both Elective and Emergent procedures). At 60 months, 76.2% of HVAD subjects and 75.1% of Control subjects were free from exchanges.
Final Effect Findings At the completion of this study, 144 (46.8%) HVAD subjects and 71 (45.2%) Control subjects were still alive. Of those, 77 (53.5%) HVAD subjects and 42 (59.2%) Control subjects were still alive on the original device.
The Kaplan-Meier survival estimate at 60 months was similar between the HVAD and Control groups: 36.7% for subjects on the HVAD and 37.4% for subjects in the Control group.

The primary cause of death in both arms was cardiovascular related (82.4% HVAD, 75.6% Control). The most common non-cardiovascular related death in both arms was infection (11.1% HVAD, 11.0% Control).

Functional Capacity: Of the patients who were alive at 60 months and had a follow up, available data for NYHA classification at baseline and 60 months was 65/77 (84.4%) for HVAD and 35/42 (83.3%) for Control. Of the 65/308 subjects in the HVAD group, there were 100% in Class III and IV at baseline and 41.6% at month 60. Of those 42/157 subjects in the Control group, 100% of subjects had Class III and IV at baseline and 31.4% at month 60.
Study Strengths & Weaknesses The strengths of the study include extended follow-up with high follow-up rates. This means longer-term data and results, including adverse events and survival, should be considered reliable estimates for the studied patients. Additionally, the majority of events were CEC adjudicated.
Study weaknesses include a high number of study deviations where assessments were not done. The completion rates for mRS assessment after stroke (a known and very serious risk associated with this device) were low (48.1% for HVAD and 45.9% for Control at 12 weeks, and 46.9% for HVAD at 51.4% for Control at 24 weeks). This makes it challenging to reliably interpret stroke severity. Additionally, quality of life measures were only reported up to 24-months post-implant.
Recommendations for Labeling Changes Even though this device is no longer being marketed, device performance data will still be of use to patients with the device implanted, and their treating physicians. A labeling update will be requested.

Cont F/u of HW004-A ENDURANCE Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 03/28/2018 04/24/2018 Overdue/Received
one year report 11/08/2018 11/13/2018 Overdue/Received
18 month report 03/28/2019 03/28/2019 On Time
two year report 09/27/2019 09/30/2019 Overdue/Received
final report 01/07/2021 01/07/2021 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

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