In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
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.
Followup Visits and Length of Followup
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.
