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

• Conditions: Ventricular Tachycardia; Sudden Cardiac Death; Heart Failure

• Registration Number: NCT04127643
• Lead Sponsor: Yonsei University

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.

Study Timeline

• Study Start: 2019-05-10
• Status Verified: 2019-10
• Study First Submitted: 2019-10-08
• Study First Submitted QC: 2019-10-13
• Last Update Submitted: 2019-10-13
• Study First Posted: 2019-10-15
• Last Update Posted: 2019-10-15
• Primary Completion: 2022-10
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative S-ICD Complication Free Rate up to 7 days post implant	7 days
1 year S-ICD Complication Free Rate	1 year
2 year S-ICD Complication Free Rate	2 year
Perioperative S-ICD Complication Free Rate up to 30 days post implant	30 days
Percentage of inappropriate shocks for AF/SVT	2 year

Secondary Outcome Measures

Name	Time	Method
Device related discomfort	2 year	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Efficacy of S-ICD therapy for spontaneous VT/VF	2 year	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.

Trial Locations

Locations (1)

Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of