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, observational, multi-site, non-randomiz+Z40ed, single arm study (please expand). This study is
designed to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease.
Study Population Description
All patients who are considered for a radio frequency ablation procedure for drug refractory sustained,
monomorphic or incessant ventricular tachycardia associated with coronary artery disease and who are eligible for treatment by a study investigator are to be screened, and then included in the study if they meet the inclusion and exclusion criteria.
Sample Size
249 total subjects and 224 evaluable subjects, 18 sites
Data Collection
Endpoints include: 1) One-year all cause mortality, 2) Cardiovascular-specific adverse event at one week, 3)
cardiac perforation, 4) pericardial effusion with hemodynamic compromise, 5) pulmonary embolus, 6) complete heart block, 7) stroke, 8) acute myocardial infarction, 9) new acute severe mitral or aortic regurgitation, 10) deep venous thrombosis, arterial dissection or injury that requires surgical treatment, and 11) death.
Followup Visits and Length of Followup
Follow-up period will be three years, with follow-up visits every 6 months.
