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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P150012 / PAS001 |
| Study Name |
INGEVITY and SAMURAI
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| Device Name |
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
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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 |
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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| Detailed Study Protocol Parameters |
| Study Objectives |
Two studies (INGEVITY and SAMURAI) have been conducted by Boston Scientific to fulfill the pre-market requirement of the INGEVITY family of leads and ImageReady MRI Conditional Pacing System (IPGs). All study visits through 12 months have already been completed for the pre-market study report. Patients in both studies will be continually followed for 60 months to fulfill the post-market requirements.
INGEVITY Study
The INGEVITY Lead Clinical Study was a prospective, multi-center, global, nonrandomized clinical study conducted to establish the safety, performance and effectiveness of theINGEVITY non-MRI Active and Passive Fixation Pace/ Sense Leads. A total of 1599 leads implanted in 1036 patients that were used for premarket endpoint analyses will be continually followed to achieve the minimum number of leads evaluable at 60 months. All patients have been consented for five years. Study procedures or clinic visits will occur every six (6) months following implant through the final 60 month visit.
SAMURAI Study
The SAMURAI Clinical Study was a prospective, multi-center, global, open-label, two-group (MRI arm and Control arm) randomized clinical study conducted to establish the safety, performance and effectiveness of the ImageReady MRI Conditional Pacing System when used in the MRI environment under the labeled Conditions of Use. A total of 351 patients from both arms implanted with an ImageReady system that were used for premarket endpoint analyses will be continually followed to achieve the minimum number of IPS system evaluable at 60 months. All patients have been consented for five years.
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| Study Population |
Subjects who were enrolled in INGEVITY study and SAMURAI study will be continually followed to achieve the proposed minimum number of leads/IPGs at 60 months. All patients have been consented for five years. There is no new enrollment proposed.
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| Sample Size |
Between the INGEVITY and SAMURAI studies, Boston Scientific has implanted or attempted 2264 INGEVITY leads across 118 sites with over 50% of the leads from the US. Each of these 2264 leads will be followed for five years, minus attrition due to patient death and withdrawal and leads taken out of service. Based on an annual attrition rate of 6.3% (observed through early 2015), the 5 year attrition rate is expected to be 27.8%. This estimated 5 year attrition rate was then used to project that approximately 1634 INGEVITY leads will complete 5 years of follow-up.
A minimum sample size of 245 leads is required to evaluate the INGEVITY Lead Post-Approval Safety Endpoint. This sample size was calculated via Monte Carlo simulations
employing Kaplan-Meier methodology, using SAS version 9.3 with the following assumptions:
Expected performance = 97.5%
Performance goal = 92.5%
Expected attrition/missing data = 27.8% (based on 6.3% annual attrition observed in the INGEVITY and SAMURAI studies)
One-sided significance level = 5%
Power = 95%
A sample size of 171 MR Scans is required to evaluate the ImageReady MR Conditional Pacing System Safety Endpoint. This sample size was calculated using the normal approximation to the binomial and confirmed via Monte Carlo simulations employing Kaplan-Meier methodology, using SAS version 9.3 with the following assumptions:
? Performance goal = 95%
? Expected MR Scan-related CFR rate between MR Scan and 1 month post-scan =99%
? One-sided significance level = 5%
? Power = 95%
To fulfill FDA post-approval requirements, there will be 75 patients with multiple MRI scans during the course of the five year follow-up.
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| Key Study Endpoints |
Primary Outcome Measures:
INGEVITY Lead Post-Approval Safety Endpoint: Lead-related Complication-Free Rate from 1 to 60 Months
ImageReady MRI Conditional Pacing System Post-Approval Safety Endpoint: MR Scan-Related Complication-Free Rate between MR Scan and 1 Month following MR Scan
Additional data includes, but is not limited to, adverse events, deaths, device deficiencies, protocol deviations, lead measurements and study visit compliance. Impacts of Multiple MRI Scans on MRI Scan-related Complications and Pacing Thresholds and Sensed Amplitudes.
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| Follow-up Visits and Length of Follow-up |
60 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
The INGEVITY study enrolled 1060 subjects and the SAMURAI study enrolled 363 subjects
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| Actual Number of Sites Enrolled |
77 sites for the INGEVITY Study and 41 sites for the SAMURAI Study
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| Patient Follow-up Rate |
A total of 1417 leads achieved five years of follow-up, satisfying the requirement of following 1000 leads to five years. The sponsor states that the 60-month lead related complication free rate was 98.7% with a lower confidence limit of 98.3% for the INGEVITY Lead Safety Endpoint of Lead-Related Complication Free Rate from 1 to 60 months.
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| Final Safety Findings |
The sponsor also states that there were 342 MR scans, and none have resulted in an MR related complication within 31 days post MR scan for the INGEVITY Lead Safety Endpoint of MR Scan-Related Complication-Free Rate.
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| Study Strengths & Weaknesses |
Overall the results of this study show that there is no concern that the lead may fail its long-term performance endpoint and that there is no concern that the system may fail that endpoint.
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| Recommendations for Labeling Changes |
FDA recommends that the sponsor update the labeling for these devices to reflect the long-term data from the Post Approval Study.
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