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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P090013 / PAS001 |
| Date Original Protocol Accepted |
02/08/2011
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| Date Current Protocol Accepted |
02/08/2011
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| Study Name |
Chronic Lead Performance/Multiple MRI
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| Device Name |
REVO MRI SURESCAN IPG AND PACING SYSTEM
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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 |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Total number of patients enrolled is 2483. This number comprised of 2323 patients in the Chronic Performance cohort and 160 patients in the Multiple Scan Characterization cohort.
Of the Chronic Performance cohort patients, 407 patients had at least one MRI and 71 of the 407 patients were implanted with Advisa MRI IPG. Of the Multiple Scan Characterization cohort patients, 146 patients had at least one MRI and 15 of the 146 were implanted with Advisa MRI IPG.
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| Actual Number of Sites Enrolled |
Seventy-five (75) sites were enrolled including 3 sites from Canada and 5 sites from India.
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| Patient Follow-up Rate |
Of 827 eligible Chronic Performance Subjects at 5 years, 702 completed the expected visit for a follow- up rate of 84.9% (702/827) at 5 years.
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| Final Safety Findings |
Primary Objective no. 1
Primary objective no. 1, which was defined as ”the MRI complication rate is less than 2% at 5 years” was
met. The 5-year MRI complication free rate was 0.0% with 95% confidence interval (CI) of 0.00% - 0.73%. The upper bound of the 95% CI of 0.73% was below the pre-specified performance goal of 2%.
Primary Objective no.2
Primary objective no. 2, which was defined as “the complication free survival probability for Model 5086MRI lead in the right ventricle (RV) is greater than 92.5% at 5 years post-implant” was met. The 5- year complication-free estimate for Model 5086MRI leads in the RV was 99.3% (95% CI: 98.7%, 99.6%). The lower bound of the 95% CI of 98.7% was above the performance goal of 92.5%. Twelve (12) RV lead related complications contributed to the study primary endpoint.
Chronic performance of the Model 5086 MRI RV lead stratified by MRI scan exposure (i.e. whether or not the lead had MRI exposure during follow-up) in a survival analysis yielded a log rank p-value of 0.71, indicating that RV lead survival times were not significantly different by lead MRI scan exposure.
Primary Objective no. 3
Primary objective no. 3, which was defined as “complication free survival probability for Model 5086MRI leads placed in the right atrium (RA) is greater than 92.5% at 5 years” was also met. The 5-year complication-free estimate for Model 5086MRI leads placed in the RA was 99.0% (95%CI: 98.3%, 99.4%). The lower bound of the 95% CI of 98.3% was above the performance goal of 92.5%. Sixteen (16) of the 17 RA lead related complications contributed to the study primary endpoint.
Chronic performance of the Model 5086 MRI RA lead stratified by MRI scan exposure in a survival analysis yielded a log rank p-value of 0.39, indicating that RA lead survival times were not significantly different by lead MRI scan exposure.
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| Study Strengths & Weaknesses |
The Chronic Lead Performance Multiple MRI study was a large (n= 2483), prospective, global, multicenter study with 5-year long term follow-up. The follow up rate at nearly all timepoints exceeded 80%. All events adjudication was performed by the Clinical Event Committee (CEC). The primary study endpoints were formally evaluated with hypothesis testing and all primary endpoints objectives were met. This study provides important information on clinical outcomes in patients implanted with the Medtronic’s Revo/Advisa MRI SureScan Systems. The absence of MRI-related complications, and
the high complication-free rate from RA lead-related complications at 5 years (lower
bound of 95% CI: 98.3%), and from RV lead-related complications at 5 years (lower bound of 95% CI: 98.7%) support the safety of the Medtronic SureScan pacing system.
The study limitations/weaknesses include visit non- compliance 47.4% (1178/2483), incomplete data collection/testing 36.0% (895/2483), and missing source document 2.0% (50/2483). The percentages were calculated based on number of subjects with the specified deviation as the numerator and total number of subjects enrolled as the denominator.
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| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long-term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post Approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow –up visits etc.), results and study strengths and limitations.
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