S-ICD® System Post Approval Study

Study Overview
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Brief Summary
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The purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the SQ-RX pulse generator and Q-TRAK electrode in a commercial clinical setting.

Detailed Description
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The S-ICD Post Approval Study is a non-randomized registry that will retrospectively enroll subjects who participated in the S-ICD Clinical Investigation (IDE G090013) and prospectively enroll new candidates for the S-ICD System. The target enrollment sample size is 1,616 subjects at up to 150 investigational sites to achieve 1,025 subjects in the analysis cohort at 60 months. The primary safety endpoint of the study is the Type I (caused by the S-ICD System) Complication Free Rate at 60 months compared to a performance goal of 85%. The primary effectiveness endpoint is the Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of ventricular tachycardia /ventricular fibrillation (VT/VF) through 60 months compared to a performance goal of 94%. The secondary safety endpoint of the study is the Electrode-Related Complication Free Rate at 60 months compared to a performance goal of 92.5%. The secondary effectiveness endpoint is First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF through 60 months compared to a performance goal of 84.0%. Additional objectives include characterization of long term safety and effectiveness in subjects of varied body habitus and in traditionally underrepresented populations. Subjects must meet the following criteria to be eligible for inclusion in the study: Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013) Willing and able to provide written informed consent or have informed consent provided by a legal representative Subjects who meet the following criteria must be excluded from the study: 1. Remaining life expectancy of less than 360 days Enrolled subjects will be followed at the implant procedure, pre-discharge and annual (±60 days) follow-up visits. Subjects are followed according to the standard of care at their participating investigational center. The primary and secondary safety and effectiveness endpoints will include a compilation of S-ICD IDE study and S-ICD PAS study subject data

Official Title
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Subcutaneous Implantable Cardioverter Defibrillator (S-ICD®) System Post Approval Study

Conditions
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Primary Prevention of Sudden Cardiac Arrest, Secondary Prevention of Sudden Cardiac Arrest

Intervention / Treatment
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* Device: S-ICD System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible for implantation with an S-ICD System, OR previously implanted with an S-ICD System in the S-ICD System Clinical Investigation (IDE G090013) AND Willing and able to provide written informed consent or have informed consent provided by a legal representative Exclusion Criteria: Remaining life expectancy of less than 360 days
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| S-ICD System Implant Attempt<br> | Device: S-ICD System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type I Complication Free Rate | Type I complications are adverse events caused by a component of the S-ICD System (i.e. pulse generator, electrode, EIT or programmer) that results in permanent loss of device function, invasive intervention or death. | 60 months (1800 days) | 
| Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF | Overall shock effectiveness refers to conversion of an episode following on any of the 5 shocks (maximum) that may be delivered during a single episode. Discrete episodes of VT/VF are those that are temporally independent (<3 within a 24 hour period), unlike storm episodes, which occur in clusters (≥3 episodes within a 24 hour period). Episodes that spontaneously terminate will be excluded from this endpoint since the effectiveness of the shock cannot be evaluated in such circumstances. | 60 months (1800 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electrode-Related Complication Free Rate. | A complication is an adverse event that results in permanent loss of device function, invasive intervention or death. | 60 months (1800 days) | 
| First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF |  | 60 months (1800 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subcutaneous implantable defibrillator, post approval study, sudden cardiac arrest, Cameron Health defibrillator