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| General |
| Study Status |
Progress Adequate |
Application Number /
Requirement Number |
P150033 / PAS002 |
| Date Original Protocol Accepted |
03/08/2016
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| Date Current Protocol Accepted |
|
| Study Name |
Micra Transcatheter Pacing System PAS
|
| Device Name |
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Detailed Study Protocol Parameters |
| Study Objectives |
Micra PAS is a global, prospective, observational, multicenter study.
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| Study Population |
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.
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| 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.
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| Key Study Endpoints |
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
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| 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.
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| Interim or Final Data Summary |
| Interim Results |
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.
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| Actual Number of Patients Enrolled |
2167 total enrolled subjects
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| Actual Number of Sites Enrolled |
184
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| Patient Follow-up Rate |
66-78 month follow up rate = 95.6%. There were 90 expected contacts with 86 completed
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| 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.
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