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...

Continued Follow-up of ENCIRCLE Premarket Cohort

General
Study Status	Study Pending
Application Number / Requirement Number	P250019 / PAS001
Date Original Protocol Accepted	02/19/2026
Date Current Protocol Accepted	02/19/2026
Study Name	Continued Follow-up of ENCIRCLE Premarket Cohort
Device Name	SAPIEN M3 Transcatheter Mitral Valve Replacement System
Clinical Trial Number(s)	NCT04153292
General Study Protocol Parameters
Study Design	Prospective Cohort Study
Data Source	New Data Collection
Comparison Group	No Control
Analysis Type	Descriptive
Study Population	Adult: At least 22 yrs
Detailed Study Protocol Parameters
Study Objectives	Continued follow-up of all living patients who were enrolled under the IDE, including those enrolled in the continued access protocol (CAP) investigation. The objective of this study is to characterize the clinical outcomes annually through 5 years post-procedure.
Study Population	All living subjects who were enrolled under the IDE.
Sample Size	All living subjects.
Key Study Endpoints	All-cause death, all stroke, heart failure rehospitalization, mitral valve reintervention, 6-minute walk test (6MWT) distance, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire score, New York Heart Association (NYHA) functional class, and echocardiographic endpoints.
Follow-up Visits and Length of Follow-up	5 years

Continued Follow-up of ENCIRCLE Premarket Cohort Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	12/22/2026
2 year report	12/22/2027
3 year report	12/21/2028
4 year report	12/21/2029
5 year report	12/22/2030

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