Skip to main content
OpenTrials
Recruiting

NCT Number: NCT02845531

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Angina Pectoris, Variant Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sudden Cardiac Death Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soon Chun Hyang University Hospital Bucheon, Bucheon-si, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Cardioverter Defibrillator

Device

Implantable Cardioverter Defibrillator and Optimal Medical Therapy

Optimal medical therapy

Drug

Primary outcomes

  1. Death from any cause

    Time frame: 5 years

Secondary outcomes

  1. Event rate of Cardiac death

    Time frame: 5 years

  2. Event rate of Death from arrhythmia

    Time frame: 5 years

  3. Event rate of Cardiac arrest

    Time frame: 5 years

  4. Event rate of Recurrence of ventricular tachyarrhythmia

    Time frame: 5 years

  5. Event rate of Hospitalization

    Time frame: 5 years

    Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia

  6. 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

  7. Event rate of Inappropriate ICD therapies

    Time frame: 5 years

  8. Event rate of Major device-related complications

    Time frame: 5 years

  9. Event rate of Stroke

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Kee-joon Choi, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Kee-joon Choi

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Acronym: VARIANT ICD

Important dates

Study start
2016
Primary completion
2030
Study completion
2031
First posted
Jul 27, 2016
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.