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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-AtriCure Synergy Ablation System


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General
Application Number P100046 / PAS001
Current Plan Approved 06/13/2014
Study Name OSB Lead-AtriCure Synergy Ablation System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
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, multi-center, observational, single arm registry study.
Study Population Description Subjects who are at least 18 years old, have non-paroxysmal forms of atrial fibrillation, are scheduled to undergo a primary open cardiac surgical procedure requiring cardiopulmonary bypass, including valve surgery, and or coronary artery bypass grafting (CABG), and who do not meet any of the exclusion criteria.



There is no control group
Sample Size The sample size of 350 subjects obtained from 50 different U.S. sites is driven by the need to test the safety hypothesis, which is that one-month serious device- and procedure-related adverse events will occur in no greater than 10% of the study population. The calculation assumes a one-sided test for statistical significance at the p < 0.05 level, 80% power, an estimated rate of 6.25%, and a maximum of 5% subject attrition at one month, providing a sample size at one month of at least 333 subjects.
Data Collection Main Endpoints

Safety: Serious device and procedure-related adverse events (not including pacemaker implantation) at one month post-procedure or during hospitalization for the procedure (whichever is longer). An independent Clinical Events Committee (CEC) will review all reported potential endpoint adverse events that occur within 30 days post-procedure, in order to make a determination on the device- or procedure-relatedness and the seriousness of the AE.



Effectiveness: Freedom from AF (i.e. no episodes lasting > 30 seconds of either atrial fibrillation, atrial flutter, or atrial tachycardia) while off of Class I and III anti-arrhythmic drugs for at least 4 weeks (except amiodarone, which the subject must be off of for 12 weeks prior to assessment), as determined by an independent core lab assessment of 48 hour Holter monitor, Zio Patch, or PPM interrogation recording, at one, two and three years post-procedure.



Secondary Endpoints

Proportion of subjects free from AF regardless of AAD usage, at one, two and three years post-procedure.

Major adverse events within 30 days post-procedure or by hospital discharge, whichever is longer, including:

Death (Included even if greater than 30 days if procedure-related)

Stroke

TIA

Myocardial infarction

Bleeding requiring > 2 units of blood and surgical intervention

Any adverse event

Serious device- and procedure-related adverse event by type of mprimary cardiac surgical procedure

Follow-up Visits and Length of Follow-up 3 years post-procedure

Clinical follow-up will be at 30 days, 4 months, and 1, 2, and 3 years post-procedure. At least three unsuccessful attempts to contact a subject who has missed a clinic visit, by telephone and certified mail, must be made before a subject will be classified as lost to follow-up.





OSB Lead-AtriCure Synergy Ablation System Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/14/2012 06/15/2012 Overdue/Received
one year report 12/13/2012 12/12/2012 On Time
18 month report 06/13/2013 06/13/2013 On Time
two year report 12/13/2013 12/16/2013 Overdue/Received
three year report 12/13/2014 12/11/2014 On Time
amended report 04/16/2015 04/16/2015 On Time
four year report 12/13/2015 12/11/2015 On Time
five year report 12/12/2016    


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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