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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-Continued Follow-Up (HW-PAS-03)

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Application Number P100047 / PAS003
Current Plan Approved 02/14/2014
Study Name OSB Lead-Continued Follow-Up (HW-PAS-03)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Multicenter, prospective, a continued follow-up study consisting of patients from the HeartWare Trials under IDE G070199
Study Population Description patients at risk of death from refractory, advanced heart failure and implanted with a HVAS under IDE G070199
Sample Size at the time of PMA and Protocol approval a total of 152 patients (30 from the HW 003 BTT study and 122 from the CAP study) were potentially eligibile for participation
Data Collection Main: Transplant, explant, death

Observational: Overall survival on device, Final patient status, Re- hospitalizations, INTERMACS adverse events, Quality of Life (QOL) measures (KCCQ and EuroQol EQ-5D-5L), Functional Status (NYHA and 6- minute walk (6MW)).
Follow-up Visits and Length of Follow-up 5 years post implant of original device and every 6 months

OSB Lead-Continued Follow-Up (HW-PAS-03) 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 11/20/2013 11/13/2013 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 11/19/2015 On Time
four year report 11/19/2016    
five year report 11/19/2017    
final report 02/19/2018    

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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