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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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Intermediate Risk Surveillance


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General
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 Number of implanting sites Not Provided in This Report

Number of subjects enrolled 2482

Follow-up rate The 30-day follow-up rate was approximately 98 percent.

Summary of Interim Results The Kaplan-Meier 30-day event rate for All-Cause Mortality was 1.6 percent, for Any Stroke it was 2.9 percent, and for Aortic Valve Re-intervention it was 0.3 percent.



Intermediate Risk Surveillance Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
three year report 01/17/2021    
four year report 01/17/2022    
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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