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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 the CLASP III Trial Cohort


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General
Study Status Study Pending
Application Number /
Requirement Number
P220003 / PAS001
Date Original Protocol Accepted 09/14/2022
Date Current Protocol Accepted  
Study Name Continued Follow-up of the CLASP III Trial Cohort
Device Name PASCAL Precision Transcatheter Valve Repair System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Continued follow-up of all living subjects who were enrolled in the pivotal cohort under the IDE. 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 in the IDE pivotal cohort.
Sample Size All living subjects.
Key Study Endpoints Major adverse events (MAEs), all-cause mortality, non-elective mitral valve re-intervention (either percutaneous or surgical), stroke, transient ischemic attack (TIA), major vascular events, renal complications, residual atrial septal defect (ASD), MR grade, 6-minute walk test (6MWT) distance, and quality of life (QoL) measures.
Follow-up Visits and Length of Follow-up 5 years


Continued Follow-up of the CLASP III Trial Cohort Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 09/14/2023    
2 year report 09/13/2024    
3 year report 09/13/2025    
4 year report 09/13/2026    
5 year report 09/13/2027    


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

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