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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P950024 / PAS001 |
| Date Original Protocol Accepted |
09/06/1996
|
| Date Current Protocol Accepted |
|
| Study Name |
Unipolar Model 4965
|
| Device Name |
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Descriptive
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The post-approval study is a 1-year, multi-center, single arm, prospective and retrospective cohort study. All subjects in the study receive the device.
|
| Study Population |
Study Population: The study population includes adults (at least 19 years old) receiving device. Indication: The Medtronic Model 4965 CapSure Epi Steroid-Eluting Unipolar Epicardial Pacing Lead is an epicardial lead designed for pacing and sensing of either the atrium or ventricle.
|
| Sample Size |
50 subjects at multiple sites
|
| Key Study Endpoints |
Endpoints include freedom from generator and lead-related adverse events and post-market performance of the lead.
|
| Follow-up Visits and Length of Follow-up |
There is no specified timeframe for follow-up visits; they occur according to the routine care plan set by each site for all cardiac surgical patients.
|
| Interim or Final Data Summary |
| Interim Results |
There are 4 deaths in 69 enrolled subjects, 2 lead events, and 8 observations to date.
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| Actual Number of Patients Enrolled |
73 subjects
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| Actual Number of Sites Enrolled |
21 centers
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| Patient Follow-up Rate |
51/73 (70%) at one year of follow-up
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| Final Safety Findings |
There were two lead-related complications and six Model 4965 lead observations. A total of 18 deaths were reported. No patient death was considered device- related. However the relatedness of 11 (61%) patient deaths to the Model 4965 could not be determined due to insufficient information.
|
| Final Effect Findings |
A total of 98 implanted Model 4965 leads were included in the analysis. The lead-related complication free survival probability at 1-year was 98.8%, with 95% CI (91.8%, 99.8%).
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| Study Strengths & Weaknesses |
A weakness of this study is that enrollment of the 73 participants took almost 14 years 12/1996- 09/2010. Over this time there may have been substantial changes in clinical practice. Additionally, this study was limited by the use of retrospective enrollment, a low follow-up rate, and substantial missingness of data. However the sponsor, will incorporate lead survival data on epicardial leads from the literature, into the labeling to supplement the findings from this study.
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| Recommendations for Labeling Changes |
Yes, labeling updates are being recommended.
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