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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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Micra Rate Resp Conf Study


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General
Study Status Completed
Application Number /
Requirement Number
P150033 / PAS001
Date Original Protocol Accepted 03/08/2016
Date Current Protocol Accepted 06/17/2020
Study Name Micra Rate Resp Conf Study
Device Name MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Medtronic is sponsoring the Micra System Post-Approval Study (PAS) to further confirm safety and effectiveness of the system when used as intended, in real-world clinical practice, following commercial release. Data will be collected from following current premarket patients and new patients.
Study Population Patients indicated for a VVIR pacemaker.
Sample Size Accounting for attrition, an estimated enrollment of 1830 patients will be required to achieve the desired sample size for the primary objectives.
Key Study Endpoints To estimate acute complication rate related to the Micra system and/or procedure: 1741 Micra system implant procedure ensure complication detection and produces a 2-sided 95% CI width of 1.0% when the event rate is 1%
To estimate the 9-year Micra related complication free survival probability: 500 patients at 9-years produces a 2-sided CI width of 6.5% with a CI lower limit of 85.0%
Follow-up Visits and Length of Follow-up The study aims to follow at least 500 patients out to 9 years. Annually
Interim or Final Data Summary
Actual Number of Patients Enrolled 43 unique patients.
Actual Number of Sites Enrolled Rate Response Study Sites:
Six (6) in US.
Pooled Data Sites:
Micra IDE: One (1) site in US.
Micra IDE: Five (5) sites OUS.
Micra China Study: Five (5) sites OUS.
Patient Follow-up Rate N/A
Final Safety Findings N/A
Final Effect Findings The Micra Rate Response sub-study confirmed the rate response operation
Study Strengths & Weaknesses Enrollment challenges led to pooling of data sets and limited diversity amongst study subjects. Study subjects skewed male.
Recommendations for Labeling Changes No recommended changes at this time.


Micra Rate Resp Conf Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
one year report 04/06/2017 04/06/2017 On Time
18 month report 10/05/2017 10/04/2017 On Time
two year report 04/06/2018 03/30/2018 On Time
30 month report 10/06/2018 10/04/2018 On Time
three year report 04/06/2019 03/29/2019 On Time
four year report 04/06/2020 04/06/2020 On Time
final report 10/05/2020 10/06/2020 Overdue/Received


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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