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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
This study is a 5-year, multi-center prospective cohort study designed to follow at least 2,000
patients implanted with BIOTRONIK's Corox OTW(-S) BP left ventricular lead.
Study Population Description
The study includes patients who require treatment for advanced heart failure through any CRT-P or
CRT-D. Patient must be successfully implanted with a BIOTRONIK CRT system, including a Corox OTW(-S) BP left ventricular lead, from 7-180 days prior to enrollment.
This post- approval registry will include a minimum of 2,500 patients from up to 100
sites in the United States with. a minimum of 600 evaluable subjects for the Corox OTW-L BP lead which assumes an equal 1/3 distribution of each lead model (Corox OTW BP LV lead, Corox OTW-S BP LV lead, and Corox OTW-L BP LV lead). The estimated sample size requirement is based on both primary safety endpoints: a non-inferiority comparison (with ä of 5%) of the overall SAE free-rate to 92.5% at 5 years, and a non-powered, superiority comparison for those individual lead-related SAE to 1% at 5 years.
Primary Endpoint 1 evaluates the overall incidence of serious adverse events related to the Corox
over-the-wire BiPolar Left Ventricular leads. Primary Endpoint 2 evaluates the incidence of each type of serious adverse events that contributes to Primary Endpoint 1.
Followup Visits and Length of Followup
Patients will be seen for routine follow-up visits per their institutional standard of care (typically
every 3-4 months for a cardiac resynchronization therapy-defibrillator and every 6 months for a cardiac resynchronization therapy-pacer), but not to exceed every 6 months.