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.
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.
Study Type
OBSERVATIONAL
Enrollment
300
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea
RECRUITINGPerioperative S-ICD Complication Free Rate up to 7 days post implant
Time frame: 7 days
Perioperative S-ICD Complication Free Rate up to 30 days post implant
Time frame: 30 days
1 year S-ICD Complication Free Rate
Time frame: 1 year
2 year S-ICD Complication Free Rate
Time frame: 2 year
Percentage of inappropriate shocks for AF/SVT
Time frame: 7 days
Percentage of inappropriate shocks for AF/SVT
Time frame: 30 days
Percentage of inappropriate shocks for AF/SVT
Time frame: 1 year
Percentage of inappropriate shocks for AF/SVT
Time frame: 2 year
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Time frame: 7 days
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Time frame: 30 days
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Time frame: 1 year
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 year
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