Post-Approval Studies (PAS) Database

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

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
Clinical Trial Number(s)	NCT02004873
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

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background