Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Yonsei University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Perioperative S-ICD Complication Free Rate up to 7 days post implant
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
- •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
Outcomes
Primary Outcomes
Perioperative S-ICD Complication Free Rate up to 7 days post implant
Time Frame: 7 days
1 year S-ICD Complication Free Rate
Time Frame: 1 year
2 year S-ICD Complication Free Rate
Time Frame: 2 year
Perioperative S-ICD Complication Free Rate up to 30 days post implant
Time Frame: 30 days
Percentage of inappropriate shocks for AF/SVT
Time Frame: 2 year
Secondary Outcomes
- Device related discomfort(2 year)
- Efficacy of S-ICD therapy for spontaneous VT/VF(2 year)