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

Heart Failure Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

• NCT number: NCT04127643
• Study type: Observational
• Source: Yonsei University
• Contact: Boyoung Jung
• Phone: +82 02-2228-8447
• Email: cby6908@yuhs.ac
• Status: Recruiting
• Start date: May 10, 2019
• Completion date: April 2024