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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127643
• Other study ID #: 1-2019-0022
• Status: Recruiting
• Start date: May 10, 2019
• Est. completion date: April 2024

Study information

• Verified date: October 2019
• Source: Yonsei University
• Contact: Boyoung Jung
• Phone: +82 02-2228-8447
• Email: cby6908[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2024
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Korea, Republic of	Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative S-ICD Complication Free Rate up to 7 days post implant		7 days
Primary	Perioperative S-ICD Complication Free Rate up to 30 days post implant		30 days
Primary	1 year S-ICD Complication Free Rate		1 year
Primary	2 year S-ICD Complication Free Rate		2 year
Primary	Percentage of inappropriate shocks for AF/SVT		7 days
Primary	Percentage of inappropriate shocks for AF/SVT		30 days
Primary	Percentage of inappropriate shocks for AF/SVT		1 year
Primary	Percentage of inappropriate shocks for AF/SVT		2 year
Secondary	Device related discomfort	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	7 days
Secondary	Device related discomfort	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	30 days
Secondary	Device related discomfort	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	1 year
Secondary	Device related discomfort	Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.	2 year
Secondary	Efficacy of S-ICD therapy for spontaneous VT/VF	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.	7 days
Secondary	Efficacy of S-ICD therapy for spontaneous VT/VF	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.	30 days
Secondary	Efficacy of S-ICD therapy for spontaneous VT/VF	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.	1 year
Secondary	Efficacy of S-ICD therapy for spontaneous VT/VF	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.	2 year