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.
Follow-up rate below 80%,
More than 10% of the primary endpoint data missing
General Study Protocol Parameters
Prospective Cohort Study
Study involve follow-up of premarket cohort (Y/N)
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
Objectives: To assess the effectiveness of current HeartWare
training procedures for the HeartWare VAS, and to
assess learning curve analysis for the non-IDE centers.
Design: A multi-center, prospective, contemporaneous control trial that will use the INTERMACS registry protocol. This study consists of four parts to provide adequate training prior to use of the device, during initial implants, and in follow-up and continuing education: (a) Surgical training, (b) On-site staff training, (c) Initial implant support and (d) Continuing education and support. New enrollment.
Study Population Description
Study groups: Patients and operators in the Newly Enrolled
Cohort PAS (HW-PAS-01) including IDE and non-IDE
The inclusion and exclusion criteria for patients enrolled in the New Cohort Post Approval Study (HW-PAS-01) are defined in that protocol.
At least 150 subjects are required to be enrolled at 12 new
The sample size
for this trial is based on the patient population from HW-PAS-01 that requires enrollment of 600 HeartWare VAS patients, of which approximately 25% (or 150) of the 600
HeartWare patients will be enrolled at non-IDE centers.
Primary effectiveness: outcomes for the IDE Experienced centers and the Non-IDE centers. The analysis involves
the time and incidence associated with the following:
1. Adverse events occurring from the date of implant to patient discharge:
o Neurologic events
o Thromboembolism o Arrhythmias
o Device malfunctions
2. Cardiopulmonary bypass (CPB) time by patient cohort
3. Acute care (ICU / CCU) duration of post implant by patient cohort
4. Incidence and rate of intra-operative device exchange by patient cohort
Followup Visits and Length of Followup
24 months post-implant.
Baseline - prior to implant, then follow-up will be conducted at 1 week,
1 month, 3 months, 6 months, 12 months, 18 months and 24 months after the initial implant