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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
S-ICD patients
patients who have received the EMBLEM S-ICD system

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yonsei University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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