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.
The objective of this sub-study is to confirm the postmarket safety and effectiveness of the
CardioMEMS¿ HF System to premarket. This is a prospective, multi-center, open-label trial conducted in the US.
Study Population Description
The sub-study patient population will consist of patients selected by an independent committee from the
PAS (Main Cohort) who are optimally managed and are clinically similar to the Control group in the CHAMPION study based on pre- enrollment data. The independent committee will identify these patients from the main cohort with NYHA Class III HF who have experienced a HF hospitalization within the past
A minimum of 256 patients will be selected by the independent committee for inclusion in
Primary safety endpoints will be evaluated at 2 years:
1) Freedom from device/system related complications
from pressure sensor failure
The primary effectiveness objective is to demonstrate that there is not a worsening in HF hospitalization rate at 1 year in the sub-study compared to the 1 year HF hospitalization rate in the CHAMPION study Control group (Part 1).
Followup Visits and Length of Followup
Implanted subjects will be evaluated at Month 1 (± 7 days) and at Months