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.
Objective: To study the long term (5 year) device safety and effectiveness in
continued follow-up of
inoperable patients who are not suitable for aortic valve surgery.
Design: A continued follow-up of cohort B, nested registries (NR1, NR4, NR5, NR6) and continued access patients in those registries. This is a prospective randomized, multi-center trial with population cohorts undergoing transcatheter heart valve replacement therapy with SAPIEN XT THV.
Study Population Description
Premarket inoperable patients who are not suitable for aortic valve surgery
A total of 1122 patients who are available for continued follow-up. Patients for
each cohort are
listed below: Cohort B: 280/560
Nested Registry 1 (NR1): 130
Nested Registry 4 (NR4): 99
Nested Registry 5 (NR5): 61
Nested Registry 6 (NR6): 50
Continued Access Registries (NR1, NR4, NR5, NR6): 502
1. Primary Safety and Effectiveness Endpoints:
¿ A non-hierarchical composite of death (all cause), disabling stroke,
and rehospitalization for symptoms of aortic stenosis.
¿ A non-hierarchical composite of all stroke, major vascular complications and reintervention.
2. Additional Safety Endpoints:
¿ Major vascular complications (VARC)
¿ All neurological events all stroke and TIA (VARC)
¿ Myocardial infarction
¿ Acute kidney injury (VARC)
¿ New permanent pacemaker
¿ Atrial fibrillation at each visit
¿ Bleeding (need for transfusion)
3. Additional Effectiveness Endpoints:
¿ Total days alive and out of hospital (from date of index procedure)
¿ Clinical improvement per NYHA Class (from baseline)
¿ Clinical improvement per Quality of Life instruments: ( Kansas City Cardiomyopathy Questionnaire [KCCQ], Euro Health Related Quality of Life [EQ5D], Short Form [SF12])