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| General |
| Study Status |
Progress Adequate |
| Application Number |
P150033 / PAS002 |
| Date Current Protocol Accepted |
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| Study Name |
Micra Transcatheter Pacing System PAS
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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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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Design Description |
Micra PAS is a global, prospective, observational, multicenter study.
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| 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.
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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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| 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
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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 Safety Information |
Number of IRB Approvals 158
Number of study sites enrolled 178 centers
Number of subjects enrolled 1829 patients enrolled.
Follow-up rate 1829 total enrolled subjects – 127 deaths /1829= 94.45%
Data Quality/Inconsistencies 71 protocol deviations were reported.
Key Safety Findings There were 175 events (in 146 patients) reported during the study. Of those, 61 in 53 patients were classified as Micra system and/or procedure-related complications by the CEC.
Key Effectiveness Findings - The mean impedance at 24 months follow- up with 48 subjects and 3 missing subjects is 571.46 +/-98.72.
- The 24-month R-wave summary mean is 14.81 +/- 4.93.
- The 24-month Pacing capture threshold is 0.66 +/-0.37.
Deaths There were 127 deaths reported. 117 were reported as not related to system or procedure. 4 deaths have been adjudicated by the CEC as procedure/system-related and 3 deaths have unknown relatedness. 3 deaths are pending CEC adjudication.
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