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General |
Study Status |
Ongoing |
Application Number / Requirement Number |
P150033 S166/ PAS001 |
Date Original Protocol Accepted |
06/07/2023
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Date Current Protocol Accepted |
 
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Study Name |
Micra Jugular Access PAS
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Device Name |
Micra AV TPS, Micra TPS
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
Sponsor Registry
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Comparison Group |
No Control
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Analysis Type |
Descriptive
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Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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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.
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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
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Sample Size |
50 subjects
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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.
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Follow-up Visits and Length of Follow-up |
30 days
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