- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04127643
Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
October 13, 2019 updated by: Yonsei University
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.
Study Overview
Status
Recruiting
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.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Boyoung Jung
- Phone Number: +82 02-2228-8447
- Email: cby6908@yuhs.ac
Study Locations
-
-
-
Seoul, Korea, Republic of, 03722
- Recruiting
- Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
-
Contact:
- Boyoung Joung, M.D., Ph.D.
- Phone Number: +82-2228-8447
- Email: CBY690@yuhs.ac
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients who have received the EMBLEM S-ICD system
Description
Inclusion Criteria:
- > 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
S-ICD patients
patients who have received the EMBLEM S-ICD system
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Perioperative S-ICD Complication Free Rate up to 7 days post implant
Time Frame: 7 days
|
7 days
|
Perioperative S-ICD Complication Free Rate up to 30 days post implant
Time Frame: 30 days
|
30 days
|
1 year S-ICD Complication Free Rate
Time Frame: 1 year
|
1 year
|
2 year S-ICD Complication Free Rate
Time Frame: 2 year
|
2 year
|
Percentage of inappropriate shocks for AF/SVT
Time Frame: 7 days
|
7 days
|
Percentage of inappropriate shocks for AF/SVT
Time Frame: 30 days
|
30 days
|
Percentage of inappropriate shocks for AF/SVT
Time Frame: 1 year
|
1 year
|
Percentage of inappropriate shocks for AF/SVT
Time Frame: 2 year
|
2 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Device related discomfort
Time Frame: 7 days
|
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
|
7 days
|
Device related discomfort
Time Frame: 30 days
|
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
|
30 days
|
Device related discomfort
Time Frame: 1 year
|
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
|
1 year
|
Device related discomfort
Time Frame: 2 year
|
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
|
2 year
|
Efficacy of S-ICD therapy for spontaneous VT/VF
Time Frame: 7 days
|
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
|
Efficacy of S-ICD therapy for spontaneous VT/VF
Time Frame: 30 days
|
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
|
Efficacy of S-ICD therapy for spontaneous VT/VF
Time Frame: 1 year
|
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
|
Efficacy of S-ICD therapy for spontaneous VT/VF
Time Frame: 2 year
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2019
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
April 1, 2024
Study Registration Dates
First Submitted
October 8, 2019
First Submitted That Met QC Criteria
October 13, 2019
First Posted (Actual)
October 15, 2019
Study Record Updates
Last Update Posted (Actual)
October 15, 2019
Last Update Submitted That Met QC Criteria
October 13, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-2019-0022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
US Department of Veterans AffairsCompleted