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.
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
Design: a non-randomized, retrospective, consecutively enrolled STS/ACC TVT Registry of all patients undergoing SAPIEN transcatheter
heart valve replacement therapy.
Study Population Description
Patients must meet the fundamental enrollment criteria of severe, symptomatic, calcific aortic stenosis with quantifiable
and documented source records. Upon meeting these eligibility criteria, the heart team shall then determine the patients risk for operative morbidity and mortality. Details of eligibility including contraindications are provided in the product Instructions for Use which are included with each SAPIEN THV and delivery system.
No comparator group.
A total of 5000 subjects combined for P110021 & P100041 patients enrolled into the STS/ACC
TVT Registry in all US sites.
Primary Safety Endpoints:
The primary safety endpoint is the clinical event of stroke at 30 days,
and again at 1 year.
2. Additional Safety Endpoints:
Additional safety endpoints will be evaluated at 30 days and one
o repeat procedure for valve-related dysfunction (surgical or interventional
Major vascular complications
Stroke (as defined in the STS/ACC TVT Registry)
3. Additional Effectiveness Endpoints:
Additional effectiveness endpoints will be evaluated at 30 days and one year:
Total days alive and out of hospital (from date of implant)
Clinical improvement per NYHA Class (from baseline)
Mean ICU and total index procedure hospital length of stay
4. Learning Curve Assessment:
The learning curve assessment will be made by analyzing the composite safety outcome according to the VARC guidelines. Additional evaluation will be performed for stroke and vascular complication. The rationale for assessment the composite at 30 day is that it is reflective of acute procedure outcomes, device performance and important potential procedure complications addressed in the Edwards SAPIEN THV Training program