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.
The post-approval study is a 5-year, multi-center, single arm, prospective and retrospective cohort study. All
subjects in the study receive the device.
Study Population Description
Study population same as approved product. Indication for use: Ovatio cardiac resynchronization therapy is indicated
for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized New York Heart Association Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer. Situs over-the-wire is designed to pace the left ventricle through a coronary vein. It is intended to be used in conjunction with ELA Medical cardiac resynchronization therapy pulse generators.
2260 subjects, 20 sites
Endpoints include complication free rate at 5 years, individual adverse event rates through 5 years,
and system complication free rate at 6 months.
Followup Visits and Length of Followup
Scheduled follow-up occurs at discharge, one month, 6 months, and every 6 months thereafter, for
five years post-implant. Unscheduled visits may occur for adverse events. At each scheduled visit, patients are queried regarding adverse events and device interrogation is performed.