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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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Intermediate Risk Surveillance

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Study Status Progress Adequate
Application Number P130021 S033/ PAS002
Date Current Protocol Accepted  
Study Name Intermediate Risk Surveillance
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Comprehensive- Linked/Registry Based Surveillance. This is prospective, non-randomized study.

The purpose of the surveillance plan is to utilize the TVT Registry to evaluate longer term the safety and device performance of the Medtronic TAVR for intermediate risk patients with symptomatic severe native aortic stenosis for 2 years following device approval. Annual clinical summaries will report long term follow-up and monitor adverse events (as collected through the TVT-R and CMS claims data) through 5 years post implant.
Study Population Description Patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 3% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical comorbidities unmeasured by the STS risk calculator).
Sample Size Subjects with an attempted implant of Medtronic TAVR within 2 years of approval for intermediate surgical risk and entered in the TVT-R from participating sites.
Data Collection Intra-procedure
Device success
At 30 days and 12 months:
All-cause mortality
All stroke
Life threatening/Major bleeding
New requirement for dialysis
Peri-procedural myocardial infarction
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Neurological (Non-stroke)
Vascular complications
Quality of life (KCCQ) outcomes At 2 – 5 years post-implantation:
All-cause mortality
All stroke
Repeat procedure for valve-related dysfunction (surgical or interventional therapy)
Follow-up Visits and Length of Follow-up 5 year post implantation.
Interim or Final Data Summary
Interim Safety Information The Kaplan-Meier (KM) rate for All-Cause Mortality was 1.4% (123 deaths) at 30 days and 7.4% (162 deaths) at 365 days; KM rate for Any Stroke was 2.8% (248 strokes in 244 subjects) at 30 days and 3.9% (95 strokes in 93 subjects) at 365 days , and for Aortic Valve Re-intervention was 0.3% (25 re-interventions in 25 subjects) at 30 days and 0.5% (10 re-interventions in 10 subjects) at 365 days.
Actual Number of Patients Enrolled 8902 subjects
Actual Number of Sites Enrolled 428 sites
Patient Follow-up Rate At 30 days, follow-up rate was 91% with 7,651 of 8,448 eligible subjects completing the follow-up visit.
At 1 year, follow-up rate was 91.4% with 2235 of 2444 eligible subjects completing the follow-up visit.

Intermediate Risk Surveillance Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
interim report 08/17/2018 08/15/2018 On Time
one year report 01/17/2019 01/16/2019 On Time
interim report 07/17/2019 07/15/2019 On Time
two year report 01/17/2020 01/16/2020 On Time
three year report 01/17/2021 01/15/2021 On Time
four year report 01/17/2022 01/14/2022 On Time
five year report 01/17/2023    

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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