S-ICD® System Post Approval Study

• Type I Complication Free Rate [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  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.
  
  
• Overall Shock Effectiveness in Converting Spontaneous Discrete Episodes of VT/VF [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  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.
  
  

• Electrode-Related Complication Free Rate. [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  A complication is an adverse event that results in permanent loss of device function, invasive intervention or death.
  
  
• First Shock Effectiveness in Converting Induced (Acute) and Spontaneous Discrete Episodes of VT/VF [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  

• Freedom from complications requiring surgical revisions of the pulse generator or electrode, including pocket revisions, surgical repositioning or removal of the device in response to product performance issues [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  
• Individual rates of each adverse event category contributing to the primary and secondary safety endpoints [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  Will be examined including two-sided 95% exact confidence intervals
  
  
• All cause mortality [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  
• Electrical performance data recorded by the device [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  
• Mechanical electrode failures [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  
• Explants and causes [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  
• Transvenous ICD (TV-ICD) implantation following subcutaneous ICD (S-ICD) explant [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  
• Surgical revisions in response to suboptimal placement or system movement [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  
• Chronic pain/discomfort requiring surgical intervention [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  
• Removal of S-ICD System in response to implant testing [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  
• Syncope associated with VT/VF episodes [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  
• Inappropriate shock incidence [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: No ]
  
• Premature battery depletions and other device malfunctions [ Time Frame: 60 months (1800 days) ] [ Designated as safety issue: Yes ]
  

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 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:

1. 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)
2. 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, predischarge and annual(±60 days) follow-up visits. Subjects are followed according to the standard of care at their participating investigational center.