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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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REVERSE Product Surveillance Registry


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General
Study Status Completed
Application Number P010031 S232/ PAS002
Date Current Protocol Accepted 01/10/2019
Study Name REVERSE Product Surveillance Registry
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 Design Description Prospective cohort study
Study Population Description All adult patients treated with a Medtronic CRT-D device, meeting the expanded indication with QRS duration < 150ms, enrolled into Medtronics Product Surveillance Registry.
Sample Size 216 investigation sites, 500 patients
Data Collection To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure hospitalization or all-cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.
To estimate the 3-year survival probability of freedom from centrally adjudicated heart failure event or all cause death for patients implanted with a Medtronic CRT-D device meeting the approved expanded indication criteria with a QRS duration < 150ms.
Follow-up Visits and Length of Follow-up 3 years, with the potential to be extended out to 5-years
every 6 months from implant through a minimum of 3-years
Interim or Final Data Summary
Actual Number of Patients Enrolled 155
Actual Number of Sites Enrolled 189
Patient Follow-up Rate 86.9%
Final Safety Findings Of the 32 deaths reported, none were adjudicated to be system or procedure related. There were 39 reported heart failure events in 25
patients, of which 38 were adjudicated to be events and 35 were heart failure hospitalizations. The Kaplan Meier survival estimate at 5 years is
66.9%. This is primarily driven by the small sample size. The observed survival rate for the composite endpoint of heart failure event or allcause death was 77.4% at 3 years.
Final Effect Findings N/A
Study Strengths & Weaknesses The study estimated the 3-year survival probability of freedom from heart failure hospitalization/event or all-cause death. There were no
significant safety concerns of device use in the expanded patient population. There were very few deviations and a high follow up rate.
The study was limited by the number of enrollments and ultimate size of the analysis cohort.
Recommendations for Labeling Changes Labeling will be updated with the clinical data available from the completed study


REVERSE Product Surveillance Registry Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/03/2012 10/03/2012 On Time
one year report 04/04/2013 04/01/2013 On Time
18 month report 10/03/2013 10/02/2013 On Time
two year report 04/04/2014 03/20/2014 On Time
three year report 04/04/2015 03/30/2015 On Time
four year report 04/03/2016 04/01/2016 On Time
five year report 04/03/2017 03/31/2017 On Time
six year report 04/03/2018 03/29/2018 On Time
seven year report 04/03/2019 03/28/2019 On Time
eight year report 04/03/2020 04/06/2020 Overdue/Received
nine year report 04/03/2021 04/01/2021 On Time
final report 04/03/2022 12/14/2021 On Time


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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