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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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Registry-Based CAP Cohort and RWU Surveillances


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General
Study Status Study Pending
Application Number P100009 S028/ PAS002
Date Current Protocol Accepted  
Study Name Registry-Based CAP Cohort and RWU Surveillances
General Study Protocol Parameters
Study Design Comprehensive/Linked/RegistryBased Surveillance
Data Source External Registry
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Comprehensive/linked/registry-based surveillances. The objectives of the surveillances are to characterize the clinical outcomes of the continued access protocol (CAP) cohort annually through 5 years post-procedure and to assess the real-world use of the commercial MitraClip System to ensure that the device is used in appropriate circumstances.
Study Population Description Patients with symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (MR; MR greater than or equal to Grade III per American Society of Echocardiography criteria) in patients with a left ventricular ejection fraction (LVEF) greater than or equal to 20% and less than or equal to 50%, and a left ventricular end systolic dimension (LVESD) less than or equal to 70 mm whose symptoms and MR severity persist despite maximally tolerated GDMT as determined by a multidisciplinary heart team experienced in the evaluation and treatment of heart failure and mitral valve disease.
Sample Size All living CAP subjects who were enrolled at participating institutions and a total of 5000 consecutively treated patients at a minimum of 100 representative institutions across the United States.
Data Collection The clinical data through one (1) year will be collected through the TVT Registry. The follow-up data (including all-cause mortality, stroke, repeat procedure for mitral valve-related dysfunction, and hospitalization) from year 2 through year 5 post procedure will be obtained through linking the TVT data with the Centers for Medicare and Medicaid Services (CMS) claims database.
Follow-up Visits and Length of Follow-up 5 years


Registry-Based CAP Cohort and RWU Surveillances Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 03/13/2020    
two year report 03/13/2021    
three year report 03/13/2022    


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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