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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 Transcatheter Pacing System PAS

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Study Status Progress Adequate
Application Number /
Requirement Number
P150033 / PAS002
Date Original Protocol Accepted 03/08/2016
Date Current Protocol Accepted  
Study Name Micra Transcatheter Pacing System PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Detailed Study Protocol Parameters
Study Objectives Micra PAS is a global, prospective, observational, multicenter study.
Study Population Patients intended to be implanted with a Micra system are eligible for enrollment into the Micra PAS.
Micra IDE (G130245) Study and the Micra Continued Access Study (G130245) patients who remain active at the time of
product approval are eligible for continued follow-up in the PAS.
Sample Size The primary objective #1 requires a minimum of 1741 patients undergoing Micra system implant attempts.
Primary objective #2 requires a sample size of 500 at 9 years. A minimum of 200 patients with a Micra system
revision will be required to characterize Micro End of Device Service. To account for attrition due to consented patient
withdrawing prior to an implant procedure, the projected enrollment number required for this study is 1830 patients.
* In order to ensure the effective sample size at the end of the study this protocol states that the study attrition will be assessed annually.
The annual attrition rate will be compared to the projected size indicated in Table 6 of the protocol (link below). If significant higher
attrition (more than 5% increase) is observed, supplemental enrollments will be considered.
Key Study Endpoints Primary Objective #1 (Acute - 30 days):
To estimate acute complication rate related to the Micra system and/or implant procedure. Individual 30-day
complication rates will be reported for but not limited to:
cardiac perforation, pericardial effusion, dislodgement, embolization, serious groin complications and infections.
- 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% Primary Objective #2 (Chronic 9 years):
To estimate the 9-year complication free survival rate of the Micra system.
- 500 patients at 9-years produces a 2-sided CI width of 6.5% with a CI lower limit of 85.0%
Secondary Objective (Micra TPS EDS):
To characterize treatment and/or procedure related to Micra TPS End of Device Service. Any one of the following
revision scenario contributes equally to the required 200 EDS events. Possible revisions scenarios include:
- Explant of Micra System with new leadless pacemaker system
- Explant of Micra System with new transvenous pacemaker system
- Implant of new leadless pacemaker without explant of Micra System
- Implant of new transvenous pacemaker system without explant of Micra System
Follow-up Visits and Length of Follow-up The study will complete when approximately 500 patients have completed 9 years of follow-up. The total estimated PAS duration is 11 years.
Interim or Final Data Summary
Interim Results Number of IRB Approvals = 114 IRB/EC approvals
Key Safety Findings:
- As of December 08, 2020: there have been 350 events reported. 349 events required CEC adjudication, and all were adjudicated. 336 events (of the 349) were considered related to the Micra system or procedure and 13 considered not related.
- There were 66 acute complications in 58 patients for an overall rate of 3.20%
- Micra system related complication free survival rate at 72-months is 94.45% with a lower 95% confidence interval of 93.27%
Key Effectiveness Findings:
The mean impedance at 72 months is 571.46 +/- 98.72
24-month R-wave summary mean is 14.81 +/- 4.93
The 24-month Pacing capture threshold is 0.66 +/- 0.37.
Actual Number of Patients Enrolled 2167 total enrolled subjects
Actual Number of Sites Enrolled 184
Patient Follow-up Rate 66-78 month follow up rate = 95.6%. There were 90 expected contacts with 86 completed
Study Strengths & Weaknesses Data Quality/Inconsistencies
152 study protocol deviation
- 264 study exits
Deaths: There have been 550 deaths with 544 considered unrelated to the system. 392 of the
deaths did not require CEC adjudication 162 were adjudicated. 1 death is pending adjudication.
The CEC classified 5 of the deaths as related to the Micra system or procedure. 4 deaths were
classified as having unknown relatedness.

Micra Transcatheter Pacing System PAS Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 10/05/2016 10/06/2016 Overdue/Received
1 year report 04/06/2017 04/06/2017 On Time
18 month report 10/05/2017 10/04/2017 On Time
2 year report 04/06/2018 03/30/2018 On Time
3 year report 04/06/2019 03/28/2019 On Time
4 year report 04/06/2020 04/06/2020 On Time
5 year report 04/05/2021 04/06/2021 Overdue/Received
6 year report 04/05/2022 04/05/2022 On Time
7 year report 04/05/2023    

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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