Post-Approval Studies (PAS) Database

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...

Registry-Based Real-World Use Surveillance

General
Study Status	Study Pending
Application Number / Requirement Number	P250024 / PAS002
Date Original Protocol Accepted	05/18/2026
Date Current Protocol Accepted	05/18/2026
Study Name	Registry-Based Real-World Use Surveillance
Device Name	Trilogy Transcatheter Heart Valve System
Clinical Trial Number(s)	NCT04415047
General Study Protocol Parameters
Study Design	Comprehensive/Linked/RegistryBased Surveillance
Data Source	External Registry
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	The Trilogy Post-Approval Surveillance Analysis is designed to assess the short-term and long-term safety and effectiveness outcomes associated with the use of the Trilogy Transcatheter Heart Valve System (Trilogy THV) in a routine clinical setting.
Study Population	Patients in the STS/ACC TVT Registry who are treated with the Trilogy THV during the 2-year enrollment period will be included. If data on greater than or equal to 2,000 patients are not available by the end of the study period, the enrollment period will be extended until at least 2,000 patients are included. Data collection will continue for under-enrolled racial and ethnic groups until each group has enrolled a minimum number of patients as specified: Black/African American, 100; Asian, 100; American Indian/Alaskan Native, 25; Native Hawaiian/Pacific Islander, 25; and Hispanic or Latino ethnicity, 100.
Sample Size	Number of subjects: greater than or equal to 2000, Data collection will continue for under-enrolled racial and ethnic groups until each group has enrolled a minimum number of patients as specified: Black/African American, 100; Asian, 100; American Indian/Alaskan Native, 25; Native Hawaiian/Pacific Islander, 25; and Hispanic or Latino ethnicity, 100. Assumptions for sample size estimation: N/A Number of sites: N/A Sites location: N/A
Key Study Endpoints	• All-cause mortality • Stroke • Aortic valve reintervention • Heart failure hospitalizations
Follow-up Visits and Length of Follow-up	30-days and 1-year through TVT-Registry. Years 2-10 through CMS link

Registry-Based Real-World Use Surveillance Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	03/17/2027
2 year report	03/16/2028
3 year report	03/16/2029
4 year report	03/16/2030
5 year report	03/16/2031

Contact Us

---

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

Additional Resources

---

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background