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.
Patients can be approached in one of two ways for enrollment: - Through patient participation in the
Promote Q CRT-D and Quartet Left Ventricular Heart Lead Study (IDE Study patients); or - Through participating centers with newly implanted patients.
1,884 new patients will be enrolled to achieve an evaluable sample size of 1,036 patients.
In addition, patients will be included for total sample size. 80 active centers enrolled in this study.
Primary endpoints: to estimate: - Freedom from system-related complications through 5 years. - Freedom from system-related complications through 5
years. - Mean of programmed LV lead pacing capture threshold across 10 pacing configurations at 5 years. Secondary endpoints: To characterize the complication rate of the Quartet Model 1458 LV Lead and to perform a trend analysis of all complications.
Followup Visits and Length of Followup
All patients will have a total duration of follow-up of 5 years from the date of
implant Patients who have a successful system implant will be seen at 6 months (+ 45 days) after implant and every 6 months (+ 60 days) thereafter until the patient reaches the 5 year visit.