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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
This is a prospective multi-center single armed study. The goal of the study is to
continue to gather clinical data on the AbioCor to permit the continued assessment of its clinical performance while in clinical use.
Study Population Description
Study Population: Patients in severe biventricular heart failure and who are not transplant candidates; not
supportable by a left ventricular assist device alone; are less than 75 years old; require multiple inotropic support; not treatable by left ventricular assist device destination therapy; not weanable from biventricular support, if applicable. Indication: Biventricular heart failure.
Sample Size
25 patients, 10 sites
Data Collection
The following outcomes will be assessed: 1) Adverse events: including neurologic events, infection, bleeding, renal
dysfunction, liver dysfunction, thrombosis, and respiratory events, 2) Quality of life using the Kansas City Cardiomyopathy Questionnaire and the EuroQol will be administered on a monthly basis while in the hospital and every three months after discharge from the hospital, 3) Characterization of patient activity and interaction with family will be monitored by the patient caregiver, 4) CVA events due to thromboembolism, 5) Discharge history to hotel, intermediary facility, or home, and readmission to hospital, 6) Functional status instruments, including distance walked and ventilatory oxygen uptake measurements, and 7) Neurological assessment, including NIH stroke scale, modified Rankin scale, and a battery of cognitive function tests
Followup Visits and Length of Followup
Post-discharge, patients will be contacted every three months. Patients will be followed until death (while
on the device) or other outcome (e.g. elective termination by family, device malfunction, etc).
