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.
Prospective/retrospective multicenter single arm cohort study
Study Population Description
Adults with New York Heart Association (NYHA) Class III Heart Failure (HF) who have experienced
a heart failure hospitalization within the past 12 months. At least 35% of the enrolled patients will be women.
The patients will serve as their own historical controls for effectiveness (1 year prior implantation).
1,200 enrolled (at least 420 women) at no more than 150 sites
At least 35% of
the enrolled patients will be women (206 completing the trial) and this data is based on the proportion seen premarket. This sample size of 206 female patients for gender evaluation will provide greater than 90% power to meet the goal for effectiveness and greater than 90% power to detect a difference as small as 0.06 from the null proportion rate of 0.90 for safety.
Primary Safety Endpoints: 1) Freedom from device/system related complications (DSRC) over 2 years in study
compared to the objective performance criterion (OPC) used in the CHAMPION trial; 2) Freedom from Pressure Sensor Failure over 2 years in study compared to the OPC used in the CHAMPION trial.
Primary Effectiveness Endpoint: Heart failure (HF) hospitalization rate over 1 year in study compared to the HF hospitalization rate in the year prior to enrollment.
Followup Visits and Length of Followup
Month 1, Month 6, and every 6 months thereafter for 2 years.
Follow-up visits will
include a physical exam, evaluation of NYHA Class, AE assessment, heart failure medications review, and assessment of any hospitalizations that may have occurred between visits.