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 in the NCDR ICD Registry will be identified, who, at the time of device implant
were diagnosed with one of the following: NYHA functional class II with non-ischemic or ischemic cardiomyopathy OR who are NYHA functional class I with ischemic cardiomyopathy
AND Have left ventricular dysfunction (EF ≤30%), prolonged intraventricular conduction (QRS ≥ 130 ms), and with a LBBB
These Registry patients will be further split into the following patient cohorts for the purposes of analysis. CRT-D group: Patients implanted with a Boston Scientific CRT-D device after the MADIT-CRT indication approval date. ICD group: Patients implanted with a Boston Scientific ICD; either, (a) after the MADIT-CRT indication approval date, or, (b) before the MADIT CRT indication approval date.
A minimum of 1300 patients who meet the specified criteria; have been implanted with a Boston
Scientific CRT-D device followed for a minimum of 5 years. A minimum of 1300 patients who meet the specified criteria; have been implanted with a Boston Scientific ICD device followed for a minimum of 5 years. A minimum of 500 Class I patients who meet the specified criteria, including a minimum of 225 who have been implanted with a with a Boston Scientific CRT-D device, have been identified and followed for a minimum of 5 years.
The primary endpoint for the study is to evaluate the -real-world- effect of CRT-D, compared to
ICD, on the time-to-all-cause mortality over a period of 5 years.
Followup Visits and Length of Followup
5-years post-implant. Progress reports will be generated every 12 months and will include: demographics, mortality, and procedural