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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 Jugular Access PAS


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General
Study Status Ongoing
Application Number /
Requirement Number
P150033 S166/ PAS001
Date Original Protocol Accepted 06/07/2023
Date Current Protocol Accepted  
Study Name Micra Jugular Access PAS
Device Name Micra AV TPS, Micra TPS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source Sponsor Registry
Comparison Group No Control
Analysis Type Descriptive
Study Population Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives The Micra Jugular Access Post Approval Study (PAS) is a prospective, observational, mutli-center study which is intended to characterize the safety and implant success of the Micra system when implant access is gained through the jugular vein.

Study Population Patients meeting the following criteria may be enrolled:

· Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements.
· Patient is intended to receive, or be treated with, an eligible Medtronic (1) Micra TPS product with a planned jugular access implant
· Patient consented before implant
· Patient who is, or will be accessible for follow-up
· Participation is not excluded by local law
· Patient is not enrolled in a concurrent drug and/or device study that may confound the PSR results

Sample Size 50 subjects

Key Study Endpoints Main effectiveness objective 1: Characterize the rate of implant success of the Micra TPS through the jugular vein. A successful implant is defined as a Micra TPS implant via the jugular vein where a functioning device is placed within the right ventricle and the closure procedure is completed with the subject being alive at closure. Success rate of 98% (49/50) expected.

Main effectiveness objective 2: Characterize the rate of access site major complications associated with the Micra TPS implant utilizing the jugular implant approach. An acute major complication will be defined as a major complication which occurs within 30-days (inclusive) of a subject’s first implant attempt. Acute major complication rate estimated to be <1%.

Ancillary objectives:
- Characterize implant technique (e.g. implant time, closure methods, implant location)
- Summarize time to ambulation post implant
- Summarize procedure related adverse events
- Summarize system related adverse events
- Characterize device electricals at implant and 30 days post-implant.

Follow-up Visits and Length of Follow-up 30 days


Micra Jugular Access PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 12/06/2023 12/05/2023 On Time
1 year report 06/06/2024 06/06/2024 On Time
18 month report 12/05/2024 12/05/2024 On Time
2 year report 06/06/2025    
3 year report 06/06/2026    


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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