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.

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Continued Follow-up of the Premarket Cohort

General
Study Status	Study Pending
Application Number / Requirement Number	P250024 / PAS001
Date Original Protocol Accepted	05/18/2026
Date Current Protocol Accepted	05/18/2026
Study Name	Continued Follow-up of the Premarket Cohort
Device Name	Trilogy Transcatheter Heart Valve System
Clinical Trial Number(s)	NCT04415047
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	Admin Database
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	The objective of this trial was to evaluate the safety and effectiveness of the Trilogy device in symptomatic patients with severe aortic regurgitation who are at a high or greater risk for surgical aortic valve replacement (SAVR). The study includes continued follow-up of patients enrolled under the IDE, including the ALIGN-AR pivotal trial and the Continued Access Protocol (CAP) investigation. Patients will be followed from years 1-5 under the IDE protocol and from years 6-10 using CMS linkage.
Study Population	Patients with symptomatic, severe aortic regurgitation (not due to acute endocarditis, rheumatic heart disease, or acute aortic dissection) who are at a high or greater risk for surgical aortic valve replacement (SAVR)
Sample Size	Years 1-5: All living patients who were enrolled under the IDE Years 6-10: The subset of patients in the ALIGN-AR and ALIGN-AR CAP studies who are = 65 years old and able to be linked to Medicare fee-for-service and Medicare Advantage claims.
Key Study Endpoints	Years 1-5 data will be collected per the study protocol and summarized descriptively, including, but not limited to: • All-cause mortality • Adverse events • Aortic valve reintervention, • Heart failure hospitalizations • Echocardiographic parameters, • Kansas City Cardiomyopathy Questionnaire (KCCQ) score • New York Heart Association (NYHA) functional classification • 6-Minute Walk Test (6MWT) distance Bioprosthetic valve failure, assessed using established echocardiographic criteria, will be reported with a minimum of 80% completeness rate each year through 5 years. Years 6-10 data will be collected from CMS Linkage: • All-cause mortality • Stroke • Aortic valve reintervention • Hospitalization (all-cause) • Heart failure hospitalizations
Follow-up Visits and Length of Follow-up	Years 1-5 under IDE protocol. Years 6-10 through CMS linkage.

Continued Follow-up of the Premarket Cohort 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

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

Additional Resources

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