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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) of 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 On-X PAS


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General
Study Status Progress Adequate
Application Number P000037 S030/ PAS001
Date Current Protocol Accepted 02/07/2017
Study Name OSB Lead-Newly Enrolled On-X PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Transit. Adolescent A (distinctively) : 18-21 yrs
Detailed Study Protocol Parameters
Study Design Description To assess the occurrence of bleeding, valve related thromboembolism and valve thrombosis with the On-X Aortic Prosthetic Heart Valve when targeted at an International Normalized Ratio (INR) level of 1.8 (1.5-2.0 range) during a 5-year follow-up period.

The study is a prospective, multicenter, observational single arm study of newly enrolled patients treated with the On-X Aortic Prosthetic Heart Valve.

Study Population Description 1. Adult patients (age 18 years or older) who have an isolated On-X aortic prosthetic heart valve implant and agreed to participate in the registry.

2. Life expectancy of at least 5 years.

3. Patients whose operation occurred within the year prior to recruitment.

The following are criteria for exclusion of patients from this study:

1. Patients having any other type of prosthetic valve implant (isolated or in combination with another valve(s)) or any On- X mitral valve; i.e. no mitral or multiple valve implants.

2. Patients with a prior history of arterial thromboembolic events, or who have such events prior to recruitment.

3. Death prior to discharge or recruitment.

4. Patients whose surgery predates enrollment by more than 1 year.

Comparison groups shall be the control groups, individually or together, as appropriate for AVR in the prior IDE trial.

Sample Size 510

The sample size for the registry was calculated with the following assumptions:

Incidence of composite outcome estimated via

Poisson regression

1-sided test comparing the composite outcome to the reference value

5% significance level

90% power

Expected overall composite proportion from the IDE

high risk treatment group (pT) = 0.0457/patient-year (ptyr)

Reference value (p95, upper 95% confidence bound from PROACT study) =0.0693/ptyr

800 patient-years of follow-up

Anticipated 5 years of follow-up per subject

Loss to follow-up over 5 years of 20%

Data Collection The primary safety endpoint is the composite of major bleeding, total TE and valve thrombosis.

Composite outcome incidence rate in:

Clinic monitored high-risk patients

Clinic monitored low-risk patients

Home monitored low-risk patients

Home monitored high-risk patients

Events are to be considered individually including subsets of bleeding and TE as secondary endpoints.

Death, reoperation and explant when associated with a primary endpoint event shall be reported.

Sudden death will also be recorded as a secondary endpoint.

Asditional Endpoints:

Peripheral TE

Minor bleeding

All bleeding (major and minor)

Ischemic stroke

TIA

Hemorrhagic stroke

Reoperation, explant, and death (associated with valve-related TE, VT, or bleeding)

Follow-up Visits and Length of Follow-up 5 years


OSB Lead-Newly Enrolled On-X PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 03/31/2016 03/04/2016 On Time
18 month report 09/29/2016 08/30/2016 On Time
two year report 03/31/2017 03/30/2017 On Time
three year report 03/31/2018    
four year report 03/31/2019    
five year report 03/30/2020    
final report 06/20/2023    


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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