Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death (VARIANT ICD)

June 23, 2026 updated by: Kee-joon Choi
The purpose of this study is to determine whether ICD(Implantable Cardioverter Defibrillator) implantation on the top of optimal medical therapy in patients with variant angina manifesting as aborted sudden cardiac death reduces the incidence of the death from any cause compared with optimal medical therapy alone.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

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.
Interventional

Enrollment (Estimated)

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.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

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

  • South Korea
      • Bucheon-si, South Korea
        • Recruiting
        • Soon Chun Hyang University Hospital Bucheon
        • Contact:
          • Hyung-o Choi, MD
        • Principal Investigator:
          • Hyung-o Choi, MD
      • Busan, South Korea
        • Recruiting
        • Dong-A Medical Center
        • Principal Investigator:
          • Jong-sung Park, MD
        • Contact:
          • Jong-sung Park, MD
      • Busan, South Korea
        • Recruiting
        • Busan National University Yangsan Hospital
        • Principal Investigator:
          • Ki-Won Hwang, MD
        • Contact:
          • Ki-Won Hwang, MD
      • Busan, South Korea
        • Active, not recruiting
        • Busan University Hospital
      • Cheonan, South Korea
        • Active, not recruiting
        • Soon Chun Hyang University Hospital Cheonan
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
          • Jongmin Hwang, MD
        • Principal Investigator:
          • Jongmin Hwang, MD
      • Daejeon, South Korea
        • Recruiting
        • Chungnam National University Hospital
        • Principal Investigator:
          • Jae-Hwan Lee, MD
        • Contact:
          • Jae-Hwan Lee, MD
      • Gangneung, South Korea
        • Withdrawn
        • Gangneung Asan Hospital
      • Gwangju, South Korea
        • Recruiting
        • Chonnam National University Hospital
        • Principal Investigator:
          • Hyung-wook Park, MD
        • Contact:
          • Hyung-wook Park, MD
      • Iksan, South Korea
        • Withdrawn
        • Wonkwang University Hospital
      • Ilsan, South Korea
        • Recruiting
        • Inje University Ilsan Paik Hospital
        • Contact:
          • Hyeon jeong Oh, MD
        • Principal Investigator:
          • Hyeon jeong Oh, MD
      • Incheon, South Korea
        • Recruiting
        • Gachon University Gil Medical Center
        • Principal Investigator:
          • Seung-Hwan Han, MD
        • Contact:
          • Seung-Hwan Han, MDD
      • Jeonju, South Korea
        • Recruiting
        • Chonbuk National University Hospital
        • Principal Investigator:
          • Kyung-seok Lee, MD
        • Contact:
          • Kyung-seok Lee, MD
      • Sejong, South Korea
        • Recruiting
        • Chungnam National University Sejong Hospital
        • Contact:
          • Minsu Kim, MD
        • Principal Investigator:
          • Minsu Kim, MD
      • Seongnam, South Korea
        • Recruiting
        • Seoul university Bundang hospital
        • Contact:
          • Il-young Oh, MD
        • Principal Investigator:
          • Il-young Oh, MD
      • Seoul, South Korea
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Principal Investigator:
          • Jun-Beom Park, MD
        • Contact:
          • Jun-Beom Park, MD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Se-il Oh, MD
        • Contact:
          • Se-il Oh, MD
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Kee-joon Choi, MD
        • Contact:
          • Kee-joon Choi, MD
      • Seoul, South Korea
        • Recruiting
        • Korea University Anam Hospital
        • Principal Investigator:
          • Young-hoon Kim, MD
        • Contact:
          • Young-hoon Kim, MD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Principal Investigator:
          • Woo-hyun Lim, MD
        • Contact:
          • Woo-hyun Lim, MD
      • Seoul, South Korea
        • Terminated
        • Korea University Guro Hospital
      • Seoul, South Korea
        • Recruiting
        • Kangdong KyungHee University hospital
        • Principal Investigator:
          • Eun-sun Jin, MD
        • Contact:
          • Eun-sun Jin, MD
      • Seoul, South Korea
        • Withdrawn
        • Severance Hospital
      • Seoul, South Korea
        • Active, not recruiting
        • The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
      • Seoul, South Korea
        • Withdrawn
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Suwon, South Korea
        • Recruiting
        • Ajou University Hospital
        • Contact:
          • Kyo-seung Hwang, MD
        • Principal Investigator:
          • Kyo-seung Hwang, MD

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia
  • Diagnosed as variant angina, defined by spontaneous coronary spasm with ST elevation (≥0.1mV) in the coronary angiogram and/or documented coronary spasm on ergonovine provocation coronary angiography

Exclusion Criteria:

  • Significant (>50%) coronary artery stenosis on coronary angiography

  • Organic heart disease known to be associated with sudden cardiac arrest.

    • Heart failure with reduced ejection fraction (Left Ventricular Ejection Fraction < 35%)
    • Presence of LV akinesia or aneurysm
    • Hypertrophic cardiomyopathy
    • Arrhythmogenic right ventricular dysplasia
  • Chronic Heart Failure New York Heart Association functional class III or IV
  • prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)
  • Prior catheter ablation for ventricular arrhythmia
  • Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)
  • Prior pacemaker or Implantable Cardioverter Defibrillator
  • 2nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker
  • Patients with poor neurologic outcome (defined as cerebral performance category scale ≥3)
  • Life expectancy <2 years
  • Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICD implantation and optimal medical therapy
Device: Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator and Optimal Medical Therapy
Active Comparator: optimal medical therapy
Drug: Optimal Medical Therapy

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
Death from any cause
Time Frame: 5 years
5 years

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
Event rate of Cardiac death
Time Frame: 5 years
5 years
Event rate of Death from arrhythmia
Time Frame: 5 years
5 years
Event rate of Cardiac arrest
Time Frame: 5 years
5 years
Event rate of Recurrence of ventricular tachyarrhythmia
Time Frame: 5 years
5 years
Event rate of Hospitalization
Time Frame: 5 years
Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia
5 years
Event rate of Appropriate ICD therapies
Time Frame: 5 years
Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously
5 years
Event rate of Inappropriate ICD therapies
Time Frame: 5 years
5 years
Event rate of Major device-related complications
Time Frame: 5 years
5 years
Event rate of Stroke
Time Frame: 5 years
5 years

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.
Kee-joon Choi

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CardioVascular Research Foundation, Korea

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.
November 29, 2016

Primary Completion (Estimated)

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.
December 1, 2030

Study Completion (Estimated)

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.
June 1, 2031

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).
July 24, 2016

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.
July 24, 2016

First Posted (Estimated)

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.
July 27, 2016

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.
June 25, 2026

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.
June 23, 2026

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.
June 1, 2026

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.
  • AMCCV2016-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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