|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P910073 S077/ PAS001 |
Date Original Protocol Accepted |
11/10/2010
|
Date Current Protocol Accepted |
01/14/2011
|
Study Name |
Longitudinal Surveillance Study
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Device Name |
ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
Sponsor Registry
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
The LSS of 4-SITE is a prospective, nonrandomized, multi-center registry of patients implanted with the 4-SITE Lead/Header system.
|
Study Population |
Patients implanted with the 4-SITE Lead/Header system
|
Sample Size |
1,780 patients.(assuming an annual attrition rate of 10%, a minimum of 1,780 patients implanted with the 4-SITE lead is necessary to obtain 5-year follow-up data on approximately 1050 patients)
|
Key Study Endpoints |
For the 4-SITE Lead/Header system, the primary endpoint for this registry will evaluate the proportion of patients without a chronic 4-SITE Lead/Header-related complication within five years post-implant.
|
Follow-up Visits and Length of Follow-up |
Five-years post implant Every six months
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
1820 subjects
|
Actual Number of Sites Enrolled |
111 sites
|
Patient Follow-up Rate |
5 years post-implant
|
Final Safety Findings |
The sponsor reported a complication-free rate through 60 months for the 4-SITE Lead/Header system of 98.9% with a one-sided 95% lower confidence limit of 98.5%. The lower confidence limit is higher than the performance goal of 92.5%. The sponsor also reported 17 adverse events that contributed to the primary endpoint. All lower confidence limits for all events types are within 1% of the complication free rate.
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Final Effect Findings |
Please see above.
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Study Strengths & Weaknesses |
The sponsor has collected sufficient data to address the primary objective of the study which was to estimate the five year Endotak Reliance 4-Site defibrillation lead related chronic complication-free rate. The Agency recommends that the sponsor update the labeling to incorporate the study findings.
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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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