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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-STOP AF PAS


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General
Application Number P100010 / PAS001
Current Plan Approved 08/31/2016
Study Name OSB Lead-STOP AF PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description This is a prospective, one-armed, multi-center, non-randomized study.
Study Population Description Patients included in this study will have:

A diagnosis of paroxysmal atrial tachycardia, with at least two episodes of atrial fibrillation in the past three months, at least one which is documented with a tracing

Age 18 and above.

Failure of treatment of atrial fibrillation (AF) with at least one drug indicated for the treatment of paroxysmal atrial fibrillation (PAF)

Presence of no exclusion criteria
Sample Size 370 enrolled with procedure attempts at 30 new user investigational sites and up to 15 STOP AF/continued access protocol AF sites with at least 70% of subject enrollment in the study come from the new user sites
Data Collection Cryoablation procedure events and chronic treatment failure at 3 years, and major adverse atrial fibrillation events.
Follow-up Visits and Length of Follow-up

The length of follow-up will be five years.

Follow-up visits will occur at discharge, 3 months, 6 months, 12 months, and 2, 3, 4, and 5 years post-procedure.



OSB Lead-STOP AF PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/17/2011 08/19/2011 Overdue/Received
one year report 12/17/2011 12/08/2011 On Time
18 month report 06/16/2012 06/14/2012 On Time
two year report 12/16/2012 12/12/2012 On Time
three year report 12/16/2013 12/16/2013 On Time
four year report 12/16/2014 12/12/2014 On Time
five year report 12/16/2015 12/14/2015 On Time
six year report 12/16/2016    


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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