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General |
Study Status |
Progress Adequate |
Application Number |
P110042 / PAS001 |
Date Current Protocol Accepted |
09/28/2012
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Study Name |
OSB Lead-S-ICD PAS Registry
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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
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Design Description |
Prospective cohort study
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Study Population Description |
Any patient, who meets the inclusion criteria, does not meet the exclusion criterion and provides informed consent will be enrolled in the registry.
Inclusion Criteria
¿X Patients eligible for implantation with an S-ICD System, OR patients previously implanted with an S-ICD System Clinical Investigation (IDE G090013)
¿X Willing and able to provide written informed consent or have informed consent a provided by a legal representative
Exclusion Criterion
¿X Remaining life expectancy of less than 360 days
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Sample Size |
1616 patients from approximately 50 investigational centers (up to 150) in the US
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Data Collection |
The primary safety endpoint of the study is the Type I Complication Free Rate at 60 months, which will be compared to a performance criterion
The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months, which will be compared to a performance criterion.
The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months, which will be compared to a performance criterion.
The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months, which will be compared to a performance criterion.
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Follow-up Visits and Length of Follow-up |
Data will be collected through the 60th month (1800 days) post implant.
Data will be collected from each patient at enrollment, implant, annual follow-up visits and from unscheduled follow up visits associated with system/procedure-related complications or spontaneous episodes.
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