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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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Cont f/u of the COAPT Trival Pivotal Cohort


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General
Study Status Study Pending
Application Number P100009 S028/ PAS001
Study Name Cont f/u of the COAPT Trival Pivotal Cohort
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 Design Description Continued follow-up of all living subjects who were enrolled in the COAPT Trial pivotal cohort. The objective of this PAS is to characterize the clinical outcomes annually through 5 years post-procedure.
Study Population Description All living subjects who were enrolled in the IDE pivotal cohort.
Sample Size All living subjects
Data Collection The key safety and effectiveness endpoints include all-cause mortality, stroke, single leaflet device attachment, device embolization, endocarditis requiring surgery, Echocardiography Core Laboratory confirmed mitral stenosis requiring surgery, heart failure (HF) related hospitalization, New York Heart Association (NYHA) classification, 6-Minute Walk Distance (6MWD) through 2 years, Kansas City Cardiomyopathy Questionnaire (KCCQ) score through 2 years, 36-Item Short Form Survey (SF-36) score through 2 years, mitral valve surgery (including type of surgery), new use of Cardiac Resynchronization Therapy (CRT), new use of single or dual chamber pacemaker, permanent left ventricular assist device (LVAD) implant, heart transplant, additional MitraClip device intervention or de novo MitraClip device intervention, including reason for intervention, number of hospitalizations and reason for hospitalization (i.e., heart failure, cardiovascular, non-cardiovascular) through 2 years, number of days alive and out of hospital, number of days hospitalized, proportion of subjects living in the baseline location, new onset of permanent atrial fibrillation, mitral stenosis, clinically significant atrial septal defect (ASD) that requires intervention, and dosages of guideline directed medical therapy (GDMT).
Follow-up Visits and Length of Follow-up 5 years


Cont f/u of the COAPT Trival Pivotal Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/12/2019   Overdue
one year report 03/13/2020    
18 month report 09/11/2020    
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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