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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110042 / PAS001 |
| Date Original Protocol Accepted |
09/28/2012
|
| Date Current Protocol Accepted |
09/28/2012
|
| Study Name |
S-ICD PAS Registry
|
| Device Name |
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective cohort study
|
| Study Population |
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
|
| Sample Size |
1616 patients from approximately 50 investigational centers (up to 150) in the US
|
| Key Study Endpoints |
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.
|
| 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.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1766
|
| Actual Number of Sites Enrolled |
86
|
| Patient Follow-up Rate |
The mean follow-up duration was 40.4 months 43.6% of the subjects completed the study. 11.0% of the subjects were lost to follow-up
|
| Final Safety Findings |
PRIMARY SAFETY:
Type I Complication Free Rate at 60 months passed the complication free rate at lower one-sided 95% confidence bound of 91.4%. This was
above the performance criteria set at 85%
SECONDARY SAFETY:
The Electrode-Related Complication Free Rate at 60 months (1800 days) passed the performance goal of 92.5% with a lower one-sided
95% confidence bound of 98.8%.
|
| Final Effect Findings |
PRIMARY EFFECTIVENESS:
The Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF through 60 months passed the performance goal of
94% with a lower one-sided 95% confidence bound of 97.4%.
SECONDARY EFFECTIVENESS:
First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months passed the
performance goal of 84% with lower one-sided 95% confidence bound of 94.1% for induced episodes and 89.8% for spontaneous discrete
episodes.
|
| Study Strengths & Weaknesses |
The safety and effectiveness primary and secondary endpoints were all acceptable. The additional pre-specified endpoints were favorable.
|
| Recommendations for Labeling Changes |
The results of the study are acceptable and should be added to the device labeling
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