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

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

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:

  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
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.

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

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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