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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-Protego DF4 Post Approval Registry


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General
Study Status Progress Adequate
Application Number P050023 S076/ PAS001
Date Current Protocol Accepted 07/03/2014
Study Name OSB Lead-Protego DF4 Post Approval Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The PAS will be a prospective, single-arm, multi-center registry. The evaluation of safety will be based on the analysis of Protego lead related adverse events. Data will be collected from up to 1694 new enrolled subjects from implant through 5 years of follow-up.
Study Population Description Subjects selected for participation should be patient population according to the indications and evaluated to meet the inclusion and exclusion criteria.

Inclusion criteria:

Implanted within the last 30 days or candidate for implantation of a BIOTRONIK ICD or CRT-D DF4 compatible system along with the Protego DF4 lead

Meets ICD or CRT-D system implant recommendations as defined in guidelines published by relevant professional societies

Able to understand the nature of the registry and provide informed consent

Available for follow-up visits on a regular basis at the investigational site for the

expected 5 years of follow-up

Age greater than or equal to 18 years

Exclusion criteria:

Enrolled in any investigational cardiac device trial

Planned cardiac surgical procedures or interventional measures within the next 6 months

Expected to receive heart transplantation or ventricular assist device within 1 year

Life expectancy of less than 1 year

Presence of another life-threatening, underlying illness separate from their cardiac disorder

Subjects reporting pregnancy at the time of enrollment

There are no comparison group
Sample Size This registry will include 1694 subjects implanted with the Protego DF4 system from up to 75 U.S. and International sites.

For primary safety endpoint 1, a total of 750 evaluable Protego leads would be required to demonstrate superiority to an AE free-rate of 92.5% (see Table 3). Assuming a 10% loss to follow-up rate per year over 5 years of follow-up (average of 8.2% of original population per year), a total of 1271 (750/0.95) subjects with a RV lead would be required to be enrolled to evaluate primary safety endpoint 1.

For primary safety endpoint 2, a total of 1000 evaluable subjects with Protego DF4 leads would be required to demonstrate a two-sided, upper 95% confidence bound of 1%, assuming an expected individual AE rate of 0.4% (see Table 3). Assuming a 10% loss to follow-up rate per year over 5 years of follow-up (average of 8.2% of original population per year), a total of 1694 (1000/0.95) subjects would be required for evaluation of primary safety endpoint 2.
Data Collection Primary Endpoints:

1. Evaluation of the overall incidence of adverse events (AEs) related to the Protego lead or device header

2. Evaluation of the incidence of each individual type of AE that contributes to Primary Endpoint 1

Secondary Endpoint:

1. Pacing threshold, sensing and impedance measurements for the Protego lead through 5 years post-implant

2. Shock impedance for the Protego lead through 5 years post-implant

3. AE rates for AEs excluded from primary safety endpoints 1 and 2, through 5 years post-implant
Follow-up Visits and Length of Follow-up 5 years post-implant


OSB Lead-Protego DF4 Post Approval Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/01/2015 01/29/2015 Overdue/Received
one year report 07/03/2015 06/26/2015 On Time
18 month report 01/01/2016 12/31/2015 On Time
two year report 07/02/2016 06/28/2016 On Time
three year report 07/02/2017 06/28/2017 On Time
four year report 07/02/2018    
five year report 07/02/2019    
six year report 07/02/2020    
seven year report 07/02/2021    
eight year report 07/02/2022    
nine year report 07/02/2023    
Final report 10/02/2024    


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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