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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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OSB Lead-Micra Transcatheter Pacing System PAS


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General
Study Status Progress Adequate
Application Number P150033 / PAS002
Date Current Protocol Accepted  
Study Name OSB Lead-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
Study Population Adult: >21
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 (>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.


OSB Lead-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    
three year report 04/06/2019    
four year report 04/05/2020    
five year report 04/05/2021    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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