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| General |
| Study Status |
Completed |
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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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
53 patients enrolled
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| Actual Number of Sites Enrolled |
13 clinical sites enrolled (7 US, 6 EU)
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| Patient Follow-up Rate |
51 patients (98.1%) completed 30-days of follow-up. 1 patient (1.9%) was lost to follow-up.
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| Final Safety Findings |
There were no major complications associated with the jugular access site.
There were four system related adverse events: one major complication (not related to procedure), two minor complications, and one observation.
There was one death due to a gastrointestinal bleed, which was classified by the independent Clinical Events Committee as unrelated to the procedure.
There were no device deficiencies or new safety concerns identified during the study.
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| Final Effect Findings |
53 patients (100%) had successful implants using jugular vein access.
Among the 53 implant procedures, 52 (98.1%) used the right jugular vein and 1 (1.9%) used the left jugular vein to obtain venous access.
Among the 53 implant procedures, 50 (94.3%) placed the device in the RV septum and 3 (5.7%) in the RV apex.
Among the 53 implant procedures, 52 (98.1%) used three or less device deployments.
Median procedure time was 20.5 minutes (IQR: 16 to 31 minutes) in the 48 patients (90.6%) with data available.
Median fluoroscopy time was 5.4 minutes (IQR: 4 to 9 minutes) in the 51 patients (96.2%) with data available.
Median time to ambulation following venous closure was 2.0 hours (IQR: 0 to 2 hours) in the 18 patients (34%) with data available.
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| Study Strengths & Weaknesses |
Strengths:
• The results appear to confirm that real-world implanting physicians can deliver the Micra TPS device successfully using a jugular venous approach without major bleeding issues.
• There was a low complication rate, with 3 total adverse events related to jugular access procedure.
Weaknesses:
• There was missing patient characteristics data that was not reportable per local laws or regulations.
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| Recommendations for Labeling Changes |
Recommend the Micra TPS device labeling is updated to include the study results.
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