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.
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
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.
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.
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)
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
Followup Visits and Length of Followup
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.