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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-Training Program (HeartWare-PAS-02)


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General
Application Number P100047 / PAS002
Current Plan Approved 09/25/2015
Study Name OSB Lead-Training Program (HeartWare-PAS-02)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objectives: To assess the effectiveness of current HeartWare

training procedures for the HeartWare VAS, and to assess learning curve analysis for the non-IDE centers.



Design: A multi-center, prospective, contemporaneous control trial that will use the INTERMACS registry protocol. This study consists of four parts to provide adequate training prior to use of the device, during initial implants, and in follow-up and continuing education: (a) Surgical training, (b) On-site staff training, (c) Initial implant support and (d) Continuing education and support. New enrollment.

Study Population Description Study groups: Patients and operators in the Newly Enrolled

Cohort PAS (HW-PAS-01) including IDE and non-IDE centers.



The inclusion and exclusion criteria for patients enrolled in the New Cohort Post Approval Study (HW-PAS-01) are defined in that protocol.

Sample Size At least 150 subjects are required to be enrolled at 12 new

centers (non-IDE).

The sample size for this trial is based on the patient population from HW-PAS-01 that requires enrollment of 600 HeartWare VAS patients, of which approximately 25% (or 150) of the 600

HeartWare patients will be enrolled at non-IDE centers.

Data Collection Primary effectiveness: outcomes for the IDE Experienced centers and the Non-IDE centers. The analysis involves the time and incidence associated with the following:

1. Adverse events occurring from the date of implant to patient discharge:

o Bleeding

o Infection

o Neurologic events

o Thromboembolism o Arrhythmias

o Device malfunctions

2. Cardiopulmonary bypass (CPB) time by patient cohort

3. Acute care (ICU / CCU) duration of post implant by patient cohort

4. Incidence and rate of intra-operative device exchange by patient cohort

Follow-up Visits and Length of Follow-up 24 months post-implant.

Baseline - prior to implant, then follow-up will be conducted at 1 week, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after the initial implant


OSB Lead-Training Program (HeartWare-PAS-02) Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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 05/16/2014 On Time
two year report 12/19/2014 12/18/2014 On Time
three year report 12/20/2015 12/16/2015 On Time
four year report 01/18/2017    
Final Report 05/19/2017    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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