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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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.

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Newly Enrolled Study

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Study Status Completed
Application Number P100041 / PAS002
Date Current Protocol Accepted 08/28/2014
Study Name Newly Enrolled Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source External Registry
Comparison Group Historical Control
Analysis Type Analytical
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
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.

Sample Size A total of 5000 subjects combined for P110021 & P100041 patients enrolled into the STS/ACC TVT Registry in all US sites.

Data Collection 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


VARC composite safety:

o all-cause mortality stroke;

o life-threatening (or disabling) bleeding

o acute kidney injury - Stage 3 (including renal replacement therapy)

o peri-procedural MI

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

Follow-up Visits and Length of Follow-up 5 years

Interim or Final Data Summary
Actual Number of Patients Enrolled 4994
Actual Number of Sites Enrolled 209
Patient Follow-up Rate year 1: >80%; year 2-5: <80%
Final Safety Findings All-cause mortality at 5 years: 64.2%

Stroke at 5 years: 13.9%

TIA at 5 years: 4.2%

Aortic Valve Re-intervention at 5 years: 3.1%

Re-intervention on Unspecified Valve at 5 years: 0.5%

New Requirement for Dialysis at 5 years: 4.8%

Final Effect Findings Survival at 5 years: 35.8%
Study Strengths & Weaknesses Strength: Large number of real-world patients enrolled in a relatively short period of time (about 10 months).

Weakness: Drop in follow-up rate post 1 year due to the inherent limitations in linking the TVT Registry with the CMS claims database.

Recommendations for Labeling Changes No. Device has been discontinued due to obsolescence.

Newly Enrolled Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
one year report 04/06/2013 04/29/2013 Overdue/Received
18 month report 10/06/2013 10/08/2013 Overdue/Received
two year report 04/06/2014 04/17/2014 Overdue/Received
three year report 04/06/2015 04/06/2015 On Time
four year report 04/06/2016 04/06/2016 On Time
five year report 04/06/2017 04/06/2017 On Time
six year report 04/06/2018 04/06/2018 On Time
final report 08/20/2018 08/22/2018 Overdue/Received

Contact Us

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

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