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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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Training Program (HeartWare-PAS-02)


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General
Study Status Completed
Application Number P100047 / PAS002
Date Current Protocol Accepted 09/25/2015
Study Name 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
Interim or Final Data Summary
Actual Number of Patients Enrolled 343 subjects were enrolled at IDE experienced sites, and 150 subjects were enrolled at non-IDE sites.
Actual Number of Sites Enrolled 28 IDE Experienced Sites and 21 non-IDE sites in the study
Patient Follow-up Rate IDE experienced sites had the following follow-up rates: Baseline (100%), Week 1 (100%), Month 1 (91.4%), Month 3 (95.2%), Month 6 (92.5%), Month 12 (96.3%), Month 18 (93.6%), Month 24 (95.4%). Non-IDE experienced sites had the following follow-up rates: Baseline (100%), Week 1 (100%), Month 1 (97.9%), Month 3 (98.5%), Month 6 (98.2%), Month 12 (98.7%), Month 18 (100%), Month 24 (97.4%).
Final Safety Findings The three most common INTERMACS adverse events were similar between the IDE Experienced and Non-IDE centers. For the IDE Experienced centers these were infection (52.8%), bleeding (35.7%), and cardiac arrhythmia (29.4%). For Non-IDE centers, the three most common events were infection (42.0%), bleeding (36.0%), and cardiac arrhythmia (31.3%). Neurologic dysfunction adverse event incidence and per person year rate were not statistically significantly different between the IDE-Experienced cohort (Incidence: 27.7% of patients, Rate per person-year: 0.29) and the non-IDE cohort (Incidence: 26.0% of patients, Rate per person-year: 0.34) through two years.
Final Effect Findings The overall survival for both IDE Experienced and Non-IDE groups was similar, with no statistically significant difference between the two groups at 24 months (p=0.8895). The overall survival rate for IDE Experienced centers was 70.9% at 24 months and for the Non-IDE centers it was 72.4% at 24 months (Kaplan-Meier estimates). From implant through two-years, the rate per person-year of rehospitalization was higher for the Non-IDE cohort (0.40 Non-IDE vs. 0.26 IDE-Experienced), but the percentage of patients experiencing rehospitalization was higher for the IDE-Experienced cohort (19.2 IDE-Experienced vs. 17.3 Non-IDE).
Study Strengths & Weaknesses Overall, the study followed a good number of patients at IDE Experienced and Non-IDE Experience centers with a high follow-up rate for each cohort and follow-up visit. However, much of the data completeness for Quality of Life and Functional Assessments were missing across study visits and centers.
Recommendations for Labeling Changes A labeling update is recommended with the outcomes of this study.


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 01/17/2017 On Time
Final Report 08/31/2017 08/31/2017 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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