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 is a prospective, observational, non-randomized, multi-center study. The study purpose is to confirm the
short-term hemodynamic effectiveness results achieved by real world providers are equivalent to the historical control established in the IDE study. Where the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation will be assessed.
Study Population Description
Consecutive subjects at each site will be invited to participate in the study if they
meet the indication for the device. This include the eExistence of a full right ventricular outflow tract conduit that was equal to or greater than 16 mm in diameter when originally implanted, and dysfunction ight ventricular outflow tract conduits with a clinical indication for intervention, including moderate or severe regurgitation or stenosis with and ight ventricular outflow tract gradient of at least 35 mmHg.
100 patients, 10-15 sites
The primary endpoint is the percentage of subjects with acceptable hemodynamic function at six months
Followup Visits and Length of Followup
Follow-up of the clinical endpoints will be conducted at baseline (pre-implant), discharge from the hospital,
at six months post-implant, one year, and annually thereafter, until the patient has been followed for five years or until the device has been explanted.