• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail

The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

Learn more...


Cont F/U of the IDE inop pts cohort(B)

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Completed
Application Number P130009 / PAS001
Date Current Protocol Accepted 08/02/2016
Study Name Cont F/U of the IDE inop pts cohort(B)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Objective: To study the long term (5 year) device safety and effectiveness in continued follow-up of cohort B and six nested registries.

Design: A continued follow-up of Cohort B and six nested registries in IDE pivotal study, a prospective randomized, multi-center trial with two population cohorts undergoing transcatheter heart valve replacement therapy with SAPIEN XT THV.

Subjects will be all pivotal and CAP Patients enrolled in Cohort B and six nested registries (NR1, NR4, NR5, NR6) and who are not suitable for aortic valve surgery (i.e. inoperable patients).

Study Population Description all pivotal and CAP Patients enrolled in Cohort B and four nested registries (NR1, NR4, NR5, NR6)
Sample Size Currently, a total of 1790 patients from pivotal trials (560 from Cohort B and 1230 from the six registries) and 775 continued access (CAP) patients from the six nested registries (as of June 2, 2014) are available for continued follow-up.
Data Collection Through TVT-Registry
Follow-up Visits and Length of Follow-up Subjects will be followed annually through 5 years. Patients have been consented for up to 5 years follow-up, thus no re-consent is needed.
Interim or Final Data Summary
Actual Number of Patients Enrolled 1042
Actual Number of Sites Enrolled 54
Patient Follow-up Rate 5-year follow-up rate of 94.7%
Final Safety Findings The 5-year CEC adjudicated KM rate was 51.3% for all-cause death and stroke, 46.0% for all-cause death, 15.4% for all-stroke, and 33.4% for rehospitalization for symptoms of aortic stenosis and/or complications of the valve procedure.
Final Effect Findings Patients showed persistent improvement from baseline in:

1. NYHA functional classification (80.7% of patients at 5 years)

2. KCCQ (change from baseline at 5 years was 15.9 +/- 1.3 for the overall summary score and 8.5 +/- 1.3

for the clinical summary score)

3. EQ-5D VAS score (change from baseline at 5 years: 6.5 +/- 1.4)

Study Strengths & Weaknesses Good THV hemodynamic valve performance was demonstrated at each follow-up visit by an improvement from baseline in EOA, mean gradient and peak gradient. At 5 years, the proportion of patients with moderate or greater total aortic regurgitation and paravalvular regurgitation was 7.6% and 6.4%, respectively.
Recommendations for Labeling Changes no need to update the labeling based on the results of the 5-year follow-up for the PIIB NR1, NR2, NR4, NR5, and NR6.

Cont F/U of the IDE inop pts cohort(B) Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 09/12/2015 09/11/2015 On Time
two year report 09/12/2016 09/09/2016 On Time
three year report 09/12/2017 09/12/2017 On Time
four year report 09/12/2018 09/11/2018 On Time
five year report/final report 09/12/2019 09/06/2019 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Related Links