|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P950024 S002/ PAS001 |
Date Original Protocol Accepted |
09/16/1999
|
Date Current Protocol Accepted |
 
|
Study Name |
Bipolar Model 4968
|
Device Name |
MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
|
General Study Protocol Parameters |
Study Design |
Prospective & Retrospective 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 5-year, multi-center, single arm, prospective and retrospective cohort study. All subjects in the study receive the device.
|
Study Population |
Study Population: Patients implanted with the device. Indication: The Medtronic Model 4968 CapSure Epi Steroid-Eluting Bipolar Epicardial Pacing Lead is an epicardial lead designed for pacing and sensing of either the atrium or ventricle.
|
Sample Size |
100 subjects at multiple sites.
|
Key Study Endpoints |
Endpoints include freedom from lead-related complications 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 subjects.
|
Interim or Final Data Summary |
Interim Results |
There have been 36 deaths in 370 subjects; 32 lead-related complications and 70 lead-related observations reported.
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Actual Number of Patients Enrolled |
370
|
Actual Number of Sites Enrolled |
85
|
Patient Follow-up Rate |
69.7%
|
Final Safety Findings |
n/a
|
Final Effect Findings |
The performance for the overall 5-year survival probability of the Model 4968 lead was 92.3%. The 5- year survival probability was 89.3% for patients 12 years old or younger, 93.9% for patients 13 ¿ 19 years of age and 98.9% for patients 20 years of age or older.
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Study Strengths & Weaknesses |
Strength: prospective, multi-center, long-term follow-up period (5 years).
Weakness: Small sample size (101 subjects in 5-year follow up), slow enrollment, extended duration of study, retrospective enrollment, high participation at 2 centers, high complications at 1 center, deviations, missing data, and use of a non-pediatric patient population.
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Recommendations for Labeling Changes |
Yes
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