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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P090013 S205/ PAS001 |
| Date Original Protocol Accepted |
04/01/2016
|
| Date Current Protocol Accepted |
|
| Study Name |
PCT Change Study
|
| Device Name |
CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
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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 Objectives |
The study will be conducted within Medtronic’s Product Surveillance Registry (PSR). The PSR platform is designed to conduct non-randomized, active,
prospective post-market surveillance. Patients implanted with a MR Conditional CIED system and enrolled in the PSR will be followed per the expected standard of care practice of their care provider. Pacing capture thresholds (PCT) measurements of MR conditional CIED systems enrolled in the PSR will be used to prospectively monitor changes in PCT following 3T MR exposure. Patient status is collected approximately every 6 to 12 months including MRI scan information, if applicable. Sites will report patient baseline information (e.g. height, weight, etc.) the occurrence of a medically indicated MRI scan, reason for scan, anatomical region scanned, magnet strength, and MRI related events.
Analysis of the primary objective will be performed 4-years following approval
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| Study Population |
All patients implanted with a MR Conditional CIED system and enrolled in the PSR who subsequently receive an MRI scan using a 3T system within the 4-years post approval that meets approved labelling requirements.
|
| Sample Size |
The following assumptions were used to estimate the PAS duration and number of 3T scans projected to be obtained during the 4-years study period:
MR Conditional CIED enrollment of approximately 2,400 patients
Annual MRI scan rate of 9%
Participating sites with 3T scanning capability: 25% - 40%
% of patients with a 3T MRI scan: 30% - 45%
Table 3: 3T Scan Rate Assumptions Over 4-Year Study Duration
Assumptions Year 1 Year 2 Year 3 Year 4
Cumulative MR Conditional Enrollments (*) 1260 1674 2047 2382
Cumulative # of completed MRI Scans 113 264 450 571
Assumption for % centers with 3T capability 25% 25% to 40%
% MR scans through 3T in these centers 30% 30% - 45%
Cumulative # of completed 3T scans 9 43 to 103
(*) Assumes a 10% annual attrition
Contribution from enrollments outside the US to the primary objective will be
limited to no more than 50% of the total sample size.
|
| Key Study Endpoints |
Primary Endpoints:
To characterize the proportion of patients implanted with an MR conditional CEID system with a pre to post MRI scan PCT measure change of more than 0.5 V following 3T scan exposure.
Definitions for pre and post PCT measurements
Pre-MRI PCT measure: max PCT value preceding the SureScan mode
enabled and prior to the 3T MRI scan
Post-MRI PCT measure: 1st max PCT measurement at a time point >30
days (chronic PCT) following 3T MRI exposure.
Further investigation will be carried out to identify root cause if the observed proportion of PCT changes following 3T scan exposure is greater than 8% (i.e. 2X the observed proportion in the PSR SureScan data) and more than 50% of those observed >0.5V PCT changes reflect an increase.
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| Follow-up Visits and Length of Follow-up |
4 years post-approval
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
8388
|
| Actual Number of Sites Enrolled |
191
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| Final Safety Findings |
One patient showed a ¿PCT greater than 0.5V within the analysis window. As this does not meet the 8% threshold proportion of patients and/or scans with a greater than 0.5V change pre- to post-3T MRI, no additional comparative analyses were performed. No adverse events, deaths, or device deficiencies related to 3T scan.
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| Final Effect Findings |
n/a
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| Study Strengths & Weaknesses |
The primary endpoint was acceptable. The results are favorable.
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| Recommendations for Labeling Changes |
The results of the study are acceptable and should be added to the device labeling.
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