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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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Study Status Completed
Application Number P030031 S011/ PAS001
Date Current Protocol Accepted 11/24/2009
Study Name 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.
Interim or Final Data Summary
Interim Safety Information No safety data is available for this study.
Actual Number of Patients Enrolled The number of patients for this subgroup analysis was 702 among the total 2,204 patients enrolled for the CABANA Trial. The 702 included

226 paroxysmal atrial fibrillation (PAF) patients randomized to the ablation arm and treated with Biosense Webster ThermoCool ablation catheters and 476 PAF patients randomized to the drug arm.
Actual Number of Sites Enrolled For this subgroup post-approval study (PAS), the ThermoCool ablation arm enrolled patients in 94 sites, and the drug arm in 56 sites

among the 126 sites for the CABANA trial.
Patient Follow-up Rate The follow-up rates in the drug and ThermoCool ablation arms are 85.9%, and 91.6%, respectively.
Final Safety Findings Primary:

The primary endpoint for this subgroup PAS is the incidence of stroke in ThermoCool ablation and drug treated PAF patients enrolled in the CABANA trial. The subgroup study results show that there is no statistically significant difference in the incidence rates of any stroke between the ablation and drug arms, i.e., 2.7% vs. 2.7%; hazard ratio of 0.93; 95%-CI of [0.34, 2.57]; and p=0.895. Therefore, the study met the primary endpoint, i.e., the ablation therapy is non-inferior to the drug therapy for treating PAF patients.

Secondary: The ablation arm shows statistically significant improvement over the drug arm for the following secondary endpoints: 1) for all-cause mortality or cardiovascular hospitalization, 49.6% vs. 58.4%, 95%-CI of [0.55, 0.86], p=0.001; 2) for cardiovascular hospitalization, 46.9% vs. 55%, 95%-CI of [0.54, 0.86], p = 0.001; and 3) for recurrent AF, 47% statistically significant reduction of AF, hazard ratio of 0.53, 95%-CI of [0.40 0.70], p<0.0001).
Study Strengths & Weaknesses This subgroup study was a randomized trial utilizing 2,204 PAF patients enrolled in the multi-center CABANA trial for providing long-term data in the incidence of stroke in the PAF patients. While one-to-one randomization was done for the CABANA trial but not for the subgroup PAS, sampling from the CABANA trial population is still a strength in this subgroup study since confounding is reduced/minimized by randomization.
Recommendations for Labeling Changes yes

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 02/03/2017 On Time
final report 05/31/2018 07/11/2018 Overdue/Received

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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