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.
Secondary Endpoints: valve thrombosis, major bleed, all paravalvular leak, major paravalvular leak, reoperation, explants, non-structural dysfunction, structural deterioration, valve related death, embolism, endocarditis, valve thrombosis, major bleed, all paravalvular leak, major paravalvular leak, reoperation, explants, nonstructural dysfunction, structural deterioration and valve-related death, New York Heart Association (NYHA) functional classification status at each interval, and hemodynamic performance at each interval.
Followup Visits and Length of Followup
Five-years post implant Annual
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Patient Followup Rate
Final Safety Findings
No Unanticipated Adverse Device Effects (UADE-s) was reported during the continued follow-up study period. The
linearized thromboembolism and endocarditis rates are statistically significantly lower than the FDA 1994 Draft Replacement Heart Valve Guidance Objective Performance Criteria (OPC).
Final Effectiveness Findings
At 5-year visit, over 90% patients maintained at NYHA I level, and valve insufficiency was
classified as either none, trivial, or mild for 98.2% of patients.
Study Strengths and Weaknesses
Strength: long-term follow-up (5 years) with over 94.7% of follow-up rate Weakness: The study population consisted
of subjects from the premarket cohort. Premarket studies are typically characterized by providers who are exceptionally skilled; and are therefore likely to provide relatively good results
Recommendations for Labeling Changes
Because neither safety nor effectiveness data presented in the final report substantially alter the labeling
already approved for the Trifecta Valve, the labeling updates for Trifecta Valve is not recommended