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
The Medtronic Post-Approval Network (PAN) is designed to conduct non-randomized, active prospective post-market Surveillance. The
Registry is sponsored by Medtronic and is comprised of a global network of hospitals, clinics and clinicians from which reliable -real world- product safety and patient clinical outcome information is generated. Primary objective: To demonstrate that the complication- free probability is greater than 92.5% at five years post- implant for the high voltage DF4 connector.
Study Population Description
This study will consist of 1,778 patients implanted with a DF- 4 connector system, enrolled at
one of approximately 150 centers globally. Subjects that meet the following inclusion criteria and do not meet any of the following exclusion criteria are eligible for enrollment. Inclusion Criteria - Subject or legally authorized representative provides written authorization and/or consent per institution and geographical requirements - Subject is implanted with a DF-4 connector system. - Subject within 30 days of implant Exclusion Criteria - Subject who is, or will be inaccessible for follow-up at a site - Subject with exclusion criteria required by local law (Europe, Central Asia [ECA] only) - Complete implant and follow-up data, including any product-related events at implant through the time of enrollment are unavailable
Accounting for attrition, a minimum enrollment of 1778 DF4 connectors are estimated to be required
in order to achieve the desired sample size for the primary objective analysis at five years.
A list of lead-related events eligible to be included in the primary objective: Failure to
capture, Failure to sense/ Undersensing, Oversensing, Threshold rise, Abnormal pacing impedance, Abnormal defibrillation impedance (RV and/or SVC coil), Lead insulation breach, Lead conductor fracture, Extra cardiac stimulation, Lead dislodgement, Cardiac perforation, Structural Lead Failure.
Followup Visits and Length of Followup
Subjects will be followed for a minimum of 5 years from their implant date. Therefore,
the expected duration of the DF4 PAS is approximately 7 years.