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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-ICD patients | patients who have received the EMBLEM S-ICD system |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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patients who have received the EMBLEM S-ICD system
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boyoung Jung | Contact | +82 02-2228-8447 | cby6908@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine | Recruiting | Seoul | 03722 | South Korea |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D016757 | Death, Sudden, Cardiac |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006323 | Heart Arrest |
| D003645 | Death, Sudden |
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| 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 |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D000075224 | Cardiac Conduction System Disease |