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

NCT ID: NCT04127643

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-10
• Study Completion Date: 2024-04-30

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.

Conditions

Heart Failure; Sudden Cardiac Death; Ventricular Tachycardia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

S-ICD patients

patients who have received the EMBLEM S-ICD system

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Boyoung Jung

Role: CONTACT

cby6908@yuhs.ac

+82 02-2228-8447

Facility Contacts

Boyoung Joung, M.D., Ph.D.

Role: primary

CBY690@yuhs.ac

+82-2228-8447

Other Identifiers

1-2019-0022

Identifier Type: -

Identifier Source: org_study_id