Heart Failure, Sudden Cardiac Death, Ventricular Tachycardia
Conditions
Keywords
S-ICD, safety, feasibility
Brief summary
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
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.
Interventions
None listed
Sponsors
Yonsei University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \> 18 years of age 2. Patients with conventional indications for ICD and; 3. Ability to provide informed consent and to complete the study and required follow-up
Exclusion criteria
1. planned cardiac surgery within 3 months of enrollment; 2. pregnancy; 3. life expectancy \<3 months; 4. indication for CRT-D or permanent ventricular pacing for new implant; 5. incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and 6. patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perioperative S-ICD Complication Free Rate up to 30 days post implant | 30 days |
| 2 year S-ICD Complication Free Rate | 2 year |
| Percentage of inappropriate shocks for AF/SVT | 7 days |
| Perioperative S-ICD Complication Free Rate up to 7 days post implant | 7 days |
| 1 year S-ICD Complication Free Rate | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of S-ICD therapy for spontaneous VT/VF | 7 days | 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. |
| Device related discomfort | 7 days | Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients. |
Countries
South Korea
Contacts
Primary ContactBoyoung Jung
Outcome results
None listed