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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-Post-Approval Study Registry


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General
Study Status Progress Adequate
Application Number P080006 S068/ PAS001
Date Current Protocol Accepted 08/01/2014
Study Name OSB Lead-Post-Approval Study Registry
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The Attain Performa PAS is a non-randomized,

observational, world-wide study with prospective data collection. Data collection will begin at patient enrollment and will continue at six-month intervals through five years post-implant. Follow-up windows consistent with typical practice have been established and will be provided to sites to facilitate a robust data set and ensure reporting consistency. Attain Performa IDE patients are eligible to continue in the PAS upon market approval if they are followed at a participating PAS study site and are

consented.

Study Population Description All patients who meet eligibility criteria and are implanted

with an Attain Performa lead will be included in analysis of the PAS objectives.



Inclusion criteria:

¿ Patient or legally authorized representative provides written authorization and/or consent per institution

and geographical requirements

¿ Patient has or is intended to receive or be treated with an eligible product

¿ Patient within enrolment window relative to therapy initiation or meets criteria for retrospective enrollment



Exclusion criteria:

¿ Patient who is, or is expected to be inaccessible for follow-up

¿ Patient with exclusion criteria required by local law

¿ Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results

There are no comparison groups
Sample Size A total of 1,778 Attain Performa leads will be enrolled in

the PAS. The study will be conducted at 150 study sites located in the United States (US), Canada, and ECA (Europe and Central Asia). Enrollment outside the United States (OUS) will be limited to no more than 50% of the overall sample size.



Enrollment of1778 Attain Performa leads results in 1050 leads followed for 5-years. This assumes a 10% per year attrition rate and provides a power of over 80% to test the primary objective. Sample size determinations must satisfy the primary objective analysis requirement and provide a reliable estimate of individual failure mode rates for the general population. The distribution of Attain Performa

lead-related complications can be expressed as binomial (n,

p=0.4%). Therefore, the probability of detecting a rare event can be calculated as a function of n.

Data Collection Study Endpoints Primary Endpoints:

To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for the Attain Performa Model 4298 lead. For the purposes of the PAS, survival from Attain Performa lead-related complications will be based on acute and chronic complications as illustrated in Table below.























/ Undersensing





Table 4 Full Protocol for: Attain PerformaTM Left Ventricular Quadripolar Lead Post-

Approval Study Registry Analysis Plan, Version 2, Date July 2, 2014

Study Element Description

Secondary Endpoint:

¿ To summarize all Attain Performa lead-related ADEs

¿ To summarize analysis results from explanted and returned Attain Performa leads



Additional analysis will be to report on incidence of pacing threshold rise per the following:

¿ At implant, pacing thresholds for the programmed

LV pacing vector that are > 3.0 Volts at > 0.4 ms

¿ At 6-months, pacing thresholds for the programmed

LV pacing vector that are > 3.5 Volts at > 0.4 ms (6- month threshold values will be regarded as the baseline for chronic thresholds)

¿ At 12-months and all eventual follow-up visits, an observed threshold increase 1.5 Volts over the 6- month values, or an absolute value > 3.5 Volts at >

0.4 ms

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

Post-approval reports will be submitted to the FDA every six

months for the first two years after the first Attain Performa

PMA-S approval, then annually thereafter.



OSB Lead-Post-Approval Study Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/30/2015 01/26/2015 On Time
one year report 08/01/2015 07/28/2015 On Time
18 month report 01/30/2016 12/17/2015 On Time
two year report 07/31/2016 07/29/2016 On Time
three year report 07/31/2017 07/24/2017 On Time
four year report 07/31/2018    
five year report 07/31/2019    


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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