Heart FailureNCT04127643
Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
An observational study of Heart Failure and Sudden Cardiac Death, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure, Sudden Cardiac Death, Ventricular Tachycardia
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2019to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have received the EMBLEM S-ICD system
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Cardiology Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 03722
Boyoung Joung, M.D., Ph.D., +82-2228-8447, CBY690@yuhs.ac
About this study
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.
Read the 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
- Keywords
- S-ICD, safety, feasibility
- Medical subject headings
- Heart Failure, Death, Sudden, Cardiac, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| S-ICD patients | patients who have received the EMBLEM S-ICD system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative S-ICD Complication Free Rate up to 7 days post implant
Measured: 7 days
Perioperative S-ICD Complication Free Rate up to 30 days post implant
Measured: 30 days
1 year S-ICD Complication Free Rate
Measured: 1 year
2 year S-ICD Complication Free Rate
Measured: 2 year
Percentage of inappropriate shocks for AF/SVT
Measured: 7 days
Percentage of inappropriate shocks for AF/SVT
Measured: 30 days
Percentage of inappropriate shocks for AF/SVT
Measured: 1 year
Percentage of inappropriate shocks for AF/SVT
Measured: 2 year
Secondary outcomes (8)
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Measured: 7 days
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Measured: 30 days
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Measured: 1 year
Device related discomfort
Device related discomfort means pain, the limitation of movement of body or any discomfort reported by the patients.
Measured: 2 year
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.
Measured: 7 days
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.
Measured: 30 days
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.
Measured: 1 year
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start10 May 2019
- Primary completionOct 2022 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127643
- Sponsor's protocol ID
- 1-2019-0022
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)
- ClinicalTrials.gov ID
- NCT04127643
- Acronym / sponsor ID
- 1-2019-0022
- Conditions
- Heart Failure, Sudden Cardiac Death, Ventricular Tachycardia
- Keywords
- S-ICD, safety, feasibility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-ICD patients | – | –patients who have received the EMBLEM S-ICD system |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have received the EMBLEM S-ICD system
Key inclusion criteria (3 listed)
- > 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative S-ICD Complication Free Rate up to 7 days post implant
Time frame: 7 days
Perioperative S-ICD Complication Free Rate up to 30 days post implant
Time frame: 30 days
1 year S-ICD Complication Free Rate
Time frame: 1 year
2 year S-ICD Complication Free Rate
Time frame: 2 year
Percentage of inappropriate shocks for AF/SVT
Time frame: 7 days
Percentage of inappropriate shocks for AF/SVT
Time frame: 30 days
Percentage of inappropriate shocks for AF/SVT
Time frame: 1 year
Percentage of inappropriate shocks for AF/SVT
Time frame: 2 year
8 secondary outcomes
Device related discomfort
Time frame: 7 days
Device related discomfort
Time frame: 30 days
Device related discomfort
Time frame: 1 year
Device related discomfort
Time frame: 2 year
Efficacy of S-ICD therapy for spontaneous VT/VF
Time frame: 7 days
Efficacy of S-ICD therapy for spontaneous VT/VF
Time frame: 30 days
Efficacy of S-ICD therapy for spontaneous VT/VF
Time frame: 1 year
Efficacy of S-ICD therapy for spontaneous VT/VF
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Sudden Cardiac Death, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boyoung Jung (+82 02-2228-8447, cby6908@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative S-ICD Complication Free Rate up to 7 days post implant (time frame: 7 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.