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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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Application Number P030031 S011/ PAS001
Current Plan Approved 11/24/2009
Study Name OSB Lead-CABANA Trial
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The purpose of this study is to provide long term data on the incidence of stroke in paroxysmal atrial fibrillation patients treated with Thermocool catheters compared to patients treated with antiarrhythmic drugs, in the CABANA Trial
Study Population Description Study Population: The proposed study is a subgroup analysis of data to be collected in the CABANA Trial. Study subjects included in the subgroup analysis will include all PAF patients treated with Thermocool catheters and all PAF patients treated with AADs. Indication: For the treatment of paroxysmal atrial fibrillation.
Sample Size A total of 3000 patients will be randomized in a 1:1 fashion to a strategy of catheter ablation (n=1500) vs. drug therapy for either rate or rhythm control (n=1500) in the CABANA Study. The sponsor anticipates that 375 (33%) patients in the ablation arm will be PAF patients treated with Thermocool catheters (33% x 75% x 1500), and 500 patients in the AAD arm will be PAF patients (33% x 1500).
Data Collection The primary endpoint for this subgroup analysis is the incidence of stroke. The sponsor will also analyze other endpoints from the CABANA Trial such as total mortality, serious bleeding and cardiac arrest.
Follow-up Visits and Length of Follow-up Patients in the trial will be randomized, treated, and followed up for a median of 3 years. Follow-up in all patients will occur at 3, 6, and 12 months during the first year, and every 6 months thereafter, with clinic visits.
Final Study Results
Interim Safety Information No safety data is available for this study.

OSB Lead-CABANA Trial Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
18 month report 08/16/2010 08/16/2010 On Time
2 year report 02/06/2011 02/02/2011 On Time
3 year report 02/06/2012 02/02/2012 On Time
4 year report 02/05/2013 02/05/2013 On Time
5 year report 02/05/2014 02/05/2014 On Time
6 year report 02/05/2015 02/04/2015 On Time
7 year report 02/05/2016 02/04/2016 On Time
8 year report 02/05/2017    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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