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

Yonsei University

Status: Unknown

Conditions: Heart Failure; Sudden Cardiac Death; Ventricular Tachycardia

Study type: Observational

Funder types: Other

Identifiers

NCT04127643

1-2019-0022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

S-ICD patients

Description:

patients who have received the EMBLEM S-ICD system