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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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MPP PAS


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General
Study Status Progress Adequate
Application Number P010031 S563/ PAS001
Study Name MPP PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Design Description A global, prospective, observational, multi-center study following patients implanted with a CRT Quad system and enrolled in the Product

Surveillance Registry per the expected standard of care practices of their care provider. The study requires regular reporting of CRT response

assessments. Data capture will be reflective of real-world clinical practice in terms of how physicians assess a patients’ response to CRT

and what actions they may take to improve response. The study provides an estimate of the nonresponder rate and estimates the

proportion of patients who are converted from a non-responder to a responder with the use of the MPP feature.
Study Population Description Patients who are considered non-responders to traditional CRT. The patient population is its own control group.
Sample Size A sample size of 1250 patients assuming 20% of the patients are identified as a surviving CRT non-responder, of which 50% have MPP

enabled produces a 95% confidence interval width of 16.5%, if the MPP responder rate is 30%. The primary objective will be analyzed when a

sample size of 118 CRT non-responders with MPP enabled is achieved or at 3 years after the approval of the MPP feature whichever comes first.
Data Collection To estimate the proportion of MPP therapy responders among patients who did not respond to standard CRT therapy.
Follow-up Visits and Length of Follow-up duration of the study
Interim or Final Data Summary
Interim Safety Information Number of IRB Approvals 56 IRB approvals

Number of study sites enrolled 56 Clinical Sites

Number of subjects enrolled 384 Subjects Enrolled

Data Quality/Inconsistencies 7 study exits, 0 deviations

Key Safety Findings 5 deaths

There were 19 reported Heart Failure Events among all patients classified as other reported events (OREs).



MPP PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 09/22/2017 09/19/2017 On Time
one year report 03/24/2018 03/22/2018 On Time
18 month report 09/22/2018 09/17/2018 On Time
two year report 03/24/2019 03/15/2019 On Time
30 month report 09/30/2019 09/30/2019 On Time
three year report 03/23/2020    
final report 06/24/2020    


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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