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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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General
Study Status Progress Adequate
Application Number P150033 / PAS002
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 Design Description Micra PAS is a global, prospective, observational, multicenter study.
Study Population Description 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.
Data Collection 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 Safety Information 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 Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/05/2016 10/06/2016 Overdue/Received
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
three year report 04/06/2019 03/28/2019 On Time
four year report 04/06/2020 04/06/2020 On Time
five year report 04/05/2021 04/06/2021 Overdue/Received
six year report 04/05/2022    


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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