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.
This study is a prospective, non-randomized, multicenter post- approval study (PAS)
Primary effectiveness: *To evaluate the hemodynamic performance
of the Mitroflow DL valve as compared to other stented aortic bioprostheses in the current literature; and
*To evaluate the overall improvements in patient condition by comparison of pre- operative and post-operative New York Heart Association (NYHA) functional classification.
Secondary safety objective: *To determine early (day 1-30) and late (>30 days) valve-related adverse event rates (including valve thrombosis, thromboembolism, paravalvular leak (all and major), bleeding (all and major) and endocarditis for Mitroflow DL are comparable to appropriate historical controls manifested as Objective Performance Criteria (OPC) in the FDA-s Heart Valve Guidance4 and the ISO 5840 guidelines. * Additional safety endpoints to be included are rates of the following adverse events: hemolysis, non-structural dysfunction, valve-related embolism, reoperation, explant, and death (all- cause and valve-related).
Study Population Description
Patients who were implanted with Mitroflow, Model DL, implantation according to the Instructions for Use (IFU).
controls specified as objective performance criteria (OPCs) in the FDA Draft Replacement Heart Valve Guidance (where applicable).
Assuming a 32% mortality and 20% attrition rate into account, the PAS will include a
minimum of 15 U.S. sites and 185 patients implanted with the Mitroflow DL valve in a commercial environment. A minimum of one-hundred (100) patients followed for at least eight (8) years will be necessary to comply with the 800 patient/year requirement outlined in the FDA Heart Valve Guidance.
Occurrence of early and late structural valve deterioration (SVD) and valve-related complications (early and late),
including valve thrombosis, thromboembolism, bleeding, anticoagulation-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, non-structural dysfunction, reoperation, explant and death.
The primary hemodynamic effectiveness endpoints for hemodynamic performance of the valve to be evaluated are trans-valvular peak and mean pressure gradients, effective orifice area (EOA) and EOA index (EOAI), performance index (PI), cardiac output (CO), cardiac index (CI), the location and severity of regurgitation, and LV mass regression.
Followup Visits and Length of Followup
8 years -Pre-implant -Implant -Post-operative (within 30 days of implant) -Annual clinical and echocardiographic follow-up