Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)

Study Overview
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Brief Summary
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S-ICD avoids the use intravascular leads and their associated risks, has been increasingly used for primary and secondary prevention of sudden death. The long-term safety and feasible of S-ICD system in Asian population with a smaller body size remain unclear. The investigators propose to perform a prospective study in Korean population to investigate the safety and feasibility of S-ICD for primary or secondary prevention of sudden cardiac death.

Detailed Description
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The investigators propose to prospectively recruit 300 patients who are qualified to receive the EMBLEM S-ICD system by following the proposed BSC Patient Screening Steps in 10 sites in Korea. All patients will be follow-up as standard of care to collect acute procedural and device related complications as well as long-term, device related, clinical and patient reported outcomes. Follow up data will be systematically collected over 24 months post-implant.

Official Title
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Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)

Conditions
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Heart Failure, Ventricular Tachycardia, Sudden Cardiac Death

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 years of age Patients with conventional indications for ICD and; Ability to provide informed consent and to complete the study and required follow-up Exclusion Criteria: planned cardiac surgery within 3 months of enrollment; pregnancy; life expectancy <3 months; indication for CRT-D or permanent ventricular pacing for new implant; incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and patients with unipolar pacemakers or implanted devices that revert to unipolar pacing

Ages Eligible for Study
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Minimum Age: 19 Years

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 patients<br>patients who have received the EMBLEM S-ICD system | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative S-ICD Complication Free Rate up to 7 days post implant |  | 7 days | 
| Perioperative S-ICD Complication Free Rate up to 30 days post implant |  | 30 days | 
| 1 year S-ICD Complication Free Rate |  | 1 year | 
| 2 year S-ICD Complication Free Rate |  | 2 year | 
| Percentage of inappropriate shocks for AF/SVT |  | 7 days | 
| Percentage of inappropriate shocks for AF/SVT |  | 30 days | 
| Percentage of inappropriate shocks for AF/SVT |  | 1 year | 
| Percentage of inappropriate shocks for AF/SVT |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device related discomfort | Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients. | 7 days | 
| Device related discomfort | Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients. | 30 days | 
| Device related discomfort | Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients. | 1 year | 
| Device related discomfort | Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients. | 2 year | 
| Efficacy of S-ICD therapy for spontaneous VT/VF | Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy. | 7 days | 
| Efficacy of S-ICD therapy for spontaneous VT/VF | Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy. | 30 days | 
| Efficacy of S-ICD therapy for spontaneous VT/VF | Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy. | 1 year | 
| Efficacy of S-ICD therapy for spontaneous VT/VF | Efficacy of S-ICD therapy for spontaneous VT/VF means the successful termination of spontaneous VT/VF by the shock delivered by S-ICD therapy. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-ICD, safety, feasibility