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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140033 / PAS001 |
| Date Original Protocol Accepted |
01/31/2017
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| Date Current Protocol Accepted |
05/22/2020
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| Study Name |
SJM Brady MRI PAS
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| Device Name |
Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
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| Clinical Trial Number(s) |
NCT01576016
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
Admin Database
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
Primary Objective: To determine the Tendril MRI RA and Tendril MRI RV lead-related complication-free rates at 5 years.
Secondary Objective: To determine the rate of cardiac tamponade or cardiac perforation events through 5 years.
The real-world approach to identify lead-related complications will use Abbott-maintained internal databases combined with CMS-maintained Medicare claims data. Every Abbott device has a unique combination of model and serial number that is preserved across Abbott databases and can be used to link data from these databases together.
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| Study Population |
All patients who has an implant of an SJM system along with a Tendril MRI RA and/or RV lead, meet inclusion/exclusion criteria, and link to Medicare FFS claims will be included in the analysis of the endpoints.
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| Sample Size |
Assuming the time to first complication follows an exponential distribution and the complication free survival at 5 years is 95%, a minimal sample size of 645 Tendril MRI RA and 645 Tendril MRI RV leads provides 80% power to reject the null hypotheses of 92.5% complication-free survival years at the 5% significance level. It is estimated that 23,230 Tendril MRI RA and 22,839 Tendril MRI RV lead implants will meet inclusion /exclusion criteria for this study, which greatly exceeds the minimal required sample size.
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| Key Study Endpoints |
Primary Endpoint: Freedom from Tendril MRI RA and/or RV lead-related complications through 5-years of follow-up.
Secondary Endpoint: The secondary outcome measure is the rate of cardiac tamponade or cardiac perforation events. The objective is to characterize the rate of these events. All cardiac tamponade and cardiac perforations will be evaluated for their relationship to the Tendril MRI RA or Tendril MRI RV leads, reported and summarized.
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| Follow-up Visits and Length of Follow-up |
The study completion is 5 years after the final implant, June 30, 2018. The data retention period will be for 2 years after the submission of the final report.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
25,601
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| Actual Number of Sites Enrolled |
N/A
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| Patient Follow-up Rate |
N/A
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| Final Safety Findings |
• Primary
o Freedom from Tendril MRI lead-related complications through 5 years of follow up
- RA leads: 98.2% (95% Lower Confidence Bound) vs Performance Goal of > 92.5%
- RV leads: 98.3% (95% Lower Confidence Bound) vs Performance Goal of > 92.5%
• Secondary
o Characterization of rate (worst-case) of cardiac tamponade events
- RA leads: 0.7378%
- RV leads: 0.6692%
o Characterization of rate (worst-case) of cardiac perforation events
-RA leads: 0.1042%
-RV leads: 0.0793%
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| Final Effect Findings |
N/A
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| Study Strengths & Weaknesses |
• Strengths
o The RWE analysis included a much larger study population compared to a traditional prospective study design.
o Fewer patients are lost to follow up in RWE studies since patients are not required to attend follow-up visits.
o The study included a wide sample of operators and institutions.
• Weaknesses
o There is an approximate lag time of 5-8 months for availability of Medicare claims data for analysis.
o RWE analysis is limited by the lack of specificity in various types of lead related complications that were determined based on diagnosis codes in Medicare claims data
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| Recommendations for Labeling Changes |
Yes, recommend including a summary of the PAS including results in the IFU manual.
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