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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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Newly Enrolled (HW-PAS-01)

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Study Status Completed
Application Number /
Requirement Number
P100047 / PAS001
Date Original Protocol Accepted 11/20/2012
Date Current Protocol Accepted 02/21/2019
Study Name Newly Enrolled (HW-PAS-01)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Objective: To evaluate the safety and efficacy of the HeartWare System in a commercial setting using data from patients enrolled in the INTERMACS database. The HeartWare VAS performance in a ¿real world¿ setting will be compared to other continuous flow, intra-corporeal left ventricular assist devices in the INTERMACS database, as assessed by primary endpoint of success and secondary endpoints including INTERMACS adverse event rates.

Design: This is a multi-center, prospective, contemporaneously controlled trial of newly enrolled patients. There will be two groups - the Treatment group, patients who receive a HeartWare VAS, and a contemporaneous Control group, patients who receive a continuous flow, intra-corporeal LVAD other than the HeartWare VAS.
Study Population Patients entered into the INTERMACS database who receive a HeartWare System (treatment group) and contemporaneous patients who receive a continuous flow, intra-corporeal LVAD other than HeartWare (control).

Inclusion criteria:
¿ FDA approved durable mechanical circulatory support device implanted
after PMA approval of the HeartWare System
¿ Signed consent for registry

Exclusion criteria:
¿ Prisoner
¿ Consent form not signed
Sample Size 600 HeartWare patients and 600 control patients of continuous flow, intra- corporeal LVADs other than the HeartWare System. A total of 1200 patients are required to satisfy the subgroups of interest (i.e. gender and race).
For Scenarios 1-2:
At least 310 implanted females and at least 310 implanted non-whites (155
HeartWare and 155 Control), calculated using a non-inferiority with a 10%
margin, using a one-sided 5% significance level, will provide 90% power at
180 days. At least 12 non-IDE sites will be included. For Scenarios 3:
The sample size of 155 patients will provide greater than 90% power to test the study hypothesis that the lower 95% (5% significance level) one-sided confidence limit is greater than 80%.
Key Study Endpoints The primary endpoint is success (alive, transplanted, or explanted for recovery) at 180 days on the originally implanted device. Patients who are explanted for recovery must survive at least 60 days post-explant. The
denominator of the simple proportion includes all enrolled and implanted patients. This will be stratified by gender and race.

Secondary endpoints are:
¿ Overall survival on device
¿ Re-hospitalizations
¿ INTERMACS adverse events
¿ Quality of Life measures (as measured by the EuroQol EQ-5D-5L and
¿ Functional Status (as measured by the 6 minute walk and / or VO2 max)
¿ Post-stroke QOL, Functional and Neurocognitive assessments

Device Malfunction and thrombus are also captured.

The INTERMACS database does not capture Modified Rankin Scale (MRS) scores, but it does capture data from which an MRS score may be derived. An independent neurologist will analyze on a blinded basis INTERMACS data for patients who have experienced a stroke event to impute MRS scores.
Follow-up Visits and Length of Follow-up Two years post implant
Follow-up will occur at discharge, 1 week, 1 month, 3 months, 6 months
Interim or Final Data Summary
Actual Number of Patients Enrolled 1200 total. 600 HVAD and 600 Competitor Device
Actual Number of Sites Enrolled 68 for HVAD patients and 114 for Competitor Device patients
Patient Follow-up Rate 96.7% Follow-up for HVAD and 97.6% Follow-up for Competitor Device
Final Safety Findings SURVIVAL
6-month survival for HVAD and the competitor device were similar and the HVAD 6-month patient success
rate (87.6%) was within the pre-specified 10% margin compared to the 6-month success rate for patients treated
with the competitor device (90.1%).
Two-year survival was numerically lower for the patients treated with HVAD (71.8%) compared to the competitor
device (77.4%). However, the study was not statistically powered to test if this was a statistically significant
The sponsor reported a statistically significant differences in the proportion of patients undergoing unplanned
rehospitalization within 6 months after implant. With HVAD patients undergoing more unplanned
rehospitalizations (65.9% undergoing unplanned rehosp.) compared to patients treated with the competitor device
(57.0% undergoing unplanned rehosp.), p=0.0148.
Adverse Event Rate Per Patient Year (In one year a single patient would average this number of events)
Total Adverse Events HVAD: 3.72 events/patient-year Control: 3.05 events/patient-year Device Malfunction/Failure &/or Pump Thrombosis HVAD: 0.23 events/patient-year Control: 0.29 events/patient-year Neurologic Dysfunction (includes CT confirmed ICVA or HCVA, Ischemic/Embolic CVA, Hemorrhagic CVA, and TIA) HVAD: 0.29 events/patient-year Control: 0.24 events/patient-year Infection HVAD: 0.85 events/patient-year Control: 0.69 events/patient-year Respiratory Failure HVAD: 0.26 events/patient-year Control: 0.16 events/patient-year Acute Cardiac Failure HVAD: 0.02 events/patient-year Control: 0.00 events/patient-year
Female patients treated with the HVAD device appeared more likely than female patients treated with the competitor device to die or to need a device replacement within 6-months.
Event Rates were Compared for Males and Females in the HVAD and Competitor Device Group. Through 2-years follow-up Using an event rate p-value cut-off of any p value less than 0.01, Women supported by HVAD were more likely than men supported by HVAD to have the following Adverse Events [Hemorrhagic CVA (Women 0.16 events/patient-year; Men 0.08 events/patient-year), Infection (Women 1.05 events/patient-year; Men 0.76 events/patient-year), Respiratory Failure (Women 0.38 events/patient-year; Men 0.21 events/patient-year), Venous Thromboembolism (Women 0.08 events/patient-year; Men 0.02 events/patient-year), Supraventricular Cardiac Arrhythmia (Women 0.15 events/patient-year; Men 0.08 events/patient-year)] Using an event rate p-value cut-off of any p value less than 0.01, Men supported by HVAD were more likely than women supported by HVAD to have the following Adverse Event: Ventricular Cardiac Arrhythmia (Women 0.08events/patient-year; Men 0.17 events/patient-year) Using an event rate p-value cut-off of any p value less than 0.01, Women supported by Competitor Device were more likely than men supported by Competitor Device to have the following Adverse Event: CT Confirmed ICVA or HCVA (Women 0.21 events/patient-year; Men 0.12 events/patient-year)
Final Effect Findings Quality of life measures including KCCQ and EQ-5D-3L were not uniformly assessed at every follow-up visit and many assessments were not completed during study visits (including baseline) for both HVAD and competitor device patients. Therefore, effectiveness findings provided are uninterpretable.
Study Strengths & Weaknesses This study followed a relatively large number of patients treated with HVAD and provided contemporaneous comparison group data on similar patients treated with a competitor device. Patient baseline characteristics bydevice type (HVAD or competitor) were determined to not be significantly different based on propensity score analysis with C-statistic comparisons. Therefore, comparisons in outcomes and adverse events can be reasonably made with the caveat that, because patients were not randomized to HVAD or competitor device, factors other than device type could influence these results.
Follow-up rates were high. This means longer-term data and results, including adverse events and survival, should be considered reliable estimates for the studied patients.
However, while this study had high follow-up rates, a lot of important data on effectiveness, quality of life, and patient outcomes after stroke (a known and very serious risk associated with this device), were inconsistently collected or largely missing across study visits. This meant that longer term results for endpoints other than survival and adverse events, were uninterpretable.
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.

Newly Enrolled (HW-PAS-01) Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 05/21/2013 05/20/2013 On Time
one year report 12/20/2013 12/17/2013 On Time
18 month report 05/21/2014 05/14/2014 On Time
two year report 12/19/2014 12/18/2014 On Time
three year report 12/20/2015 12/15/2015 On Time
four year report 01/18/2017 01/13/2017 On Time
Final Validation Report 05/22/2017 05/22/2017 On Time
Final Report 02/01/2020 02/03/2020 Overdue/Received

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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