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.
Extended follow-up study of all available subjects that were enrolled in the Medtronic CoreValve® U.S.
Pivotal Trial and Continued Access Study who received the Medtronic CoreValve® System (MCS) or underwent surgical aortic valve replacement (SAVR).
Study Population Description
High risk and extreme risk subjects currently consented to and enrolled in the Medtronic U.S.
Pivotal Trial and Continued Access Study who received the MCS or underwent SAVR.
All available subjects enrolled in the US Pivotal Trial, 394 subjects randomized to transcatheter aortic
valve replacement (TAVR) and 401 subjects randomized to surgical aortic valve replacement (SAVR), and 76 roll-in subjects in all sites (up to 45) and approximately 2800 CAP subjects.
The primary endpoint of all-cause mortality at 12 months in High Risk subjects is non-inferior
to surgical aortic valve replacement (SAVR), has been met. Clinical outcomes will be characterized annually through 5 years. The secondary endpoints through 12 months have been evaluated. The following secondary endpoints will characterize clinical outcomes annually through 5 years: A. Major Adverse Cardiovascular and Cerebrovascular Event (MACCE) event rates via Kaplan-Meier. MACCE is defined as a composite of: - all-cause death - myocardial infarction (MI) - all stroke, and - reintervention (defined as any cardiac surgery or percutaneous reintervention catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve) 2. The occurrence of individual MACCE components event rates via Kaplan-Meier 3. Major Adverse Events (MAE) event rates via Kaplan-Meier 4. Conduction disturbance requiring permanent pacemaker implantation event rates via Kaplan-Meier 5. Change in NYHA class 6. Quality of Life (QoL) change using the following measures: - Kansas City Cardiomyopathy Questionnaire (KCCQ) - SF 12, and - EuroQoL 7. Echocardiographic assessment of valve performance using the following measures: - transvalvular mean gradient - effective orifice area - degree of aortic valve regurgitation (transvalvular and paravalvular) 8. Aortic valve disease hospitalization event rates via Kaplan-Meier 9. Cardiovascular deaths and valve-related deaths event rates via Kaplan-Meier 10.Strokes (of any severity) and TIAs event rates via Kaplan-Meier 11.Evidence of prosthetic valve dysfunction
Followup Visits and Length of Followup
Annually through 5 years
OSB Lead-Continued f/u of the premarket cohorts