Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2019
CompletedFirst Submitted
Initial submission to the registry
October 8, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedOctober 15, 2019
October 1, 2019
3.4 years
October 8, 2019
October 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Perioperative S-ICD Complication Free Rate up to 7 days post implant
7 days
Perioperative S-ICD Complication Free Rate up to 30 days post implant
30 days
1 year S-ICD Complication Free Rate
1 year
2 year S-ICD Complication Free Rate
2 year
Percentage of inappropriate shocks for AF/SVT
7 days
Percentage of inappropriate shocks for AF/SVT
30 days
Percentage of inappropriate shocks for AF/SVT
1 year
Percentage of inappropriate shocks for AF/SVT
2 year
Secondary Outcomes (8)
Device related discomfort
7 days
Device related discomfort
30 days
Device related discomfort
1 year
Device related discomfort
2 year
Efficacy of S-ICD therapy for spontaneous VT/VF
7 days
- +3 more secondary outcomes
Study Arms (1)
S-ICD patients
patients who have received the EMBLEM S-ICD system
Eligibility Criteria
patients who have received the EMBLEM S-ICD system
You may qualify if:
- \> 18 years of age
- Patients with conventional indications for ICD and;
- Ability to provide informed consent and to complete the study and required follow-up
You may not qualify if:
- planned cardiac surgery within 3 months of enrollment;
- pregnancy;
- life expectancy \<3 months;
- indication for CRT-D or permanent ventricular pacing for new implant;
- incessant ventricular tachycardia and/or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing; and
- patients with unipolar pacemakers or implanted devices that revert to unipolar pacing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2019
First Posted
October 15, 2019
Study Start
May 10, 2019
Primary Completion
October 1, 2022
Study Completion
April 1, 2024
Last Updated
October 15, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share