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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Newly Enrolled (HW-PAS-01)

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Application Number P100047 / PAS001
Current Plan Approved 01/15/2016
Study Name OSB Lead-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 Design Description 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 Description 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%.

Data Collection 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

OSB Lead-Newly Enrolled (HW-PAS-01) Schedule

Report 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    
five year report 11/19/2017    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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