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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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Continued Follow-up of SUMMIT MAC Premarket Cohort


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General
Study Status Study Pending
Application Number /
Requirement Number		 P240042 / PAS001
Date Original Protocol Accepted 05/23/2025
Date Current Protocol Accepted  
Study Name Continued Follow-up of SUMMIT MAC Premarket Cohort
Device Name Tendyne Transcatheter Mitral Valve System
Clinical Trial Number(s) NCT03433274 
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of all living Severe MAC cohort subjects 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 Severe MAC cohort subjects who were enrolled under the IDE.
Sample Size All living subjects.
Key Study Endpoints All-cause mortality, all stroke, cardiovascular hospitalization, number of days alive and out of hospital, annualized rate of HFH, mitral valve reintervention or reoperation, 6MWT distance, KCCQ score, EQ-5D-5L score, SF-12 score, NYHA functional class, and echocardiographic endpoints.
Follow-up Visits and Length of Follow-up 5 years.


Continued Follow-up of SUMMIT MAC Premarket Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 05/23/2026    
2 year report 05/23/2027    
3 year report 05/22/2028    
4 year report 05/22/2029    
5 year report 05/22/2030    


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

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