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NCT02845531RecruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
140 (estimated)
First submitted
24 Jul 2016
Start date
29 Nov 2016
Primary completion date
Dec 2030
Lead sponsor
Kee-joon Choi
NCT number
NCT02845531

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 140
  • From 29 Nov 2016 to the primary completion date, Dec 2030
  • 26 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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
  • Prior pacemaker or Implantable Cardioverter Defibrillator

Other illness

  • Chronic Heart Failure New York Heart Association functional class III or IV
  • Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up

Lab values

  • 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
  • Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)

Age

  • Life expectancy \<2 years

Other

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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Soon Chun Hyang University Hospital Bucheon
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Bucheon-siSouth KoreaRecruiting
Busan University Hospital
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BusanSouth KoreaActive, not recruiting
Dong-A Medical Center
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BusanSouth KoreaRecruiting
Busan National University Yangsan Hospital
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BusanSouth KoreaRecruiting
Soon Chun Hyang University Hospital Cheonan
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CheonanSouth KoreaActive, not recruiting
Keimyung University - Dongsan Medical Center
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DaeguSouth KoreaRecruiting
Chungnam National University Hospital
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DaejeonSouth KoreaRecruiting
Gangneung Asan Hospital
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GangneungSouth KoreaWithdrawn
Chonnam National University Hospital
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GwangjuSouth KoreaRecruiting
Wonkwang University Hospital
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IksanSouth KoreaWithdrawn
Inje University Ilsan Paik Hospital
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IlsanSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Chonbuk National University Hospital
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JeonjuSouth KoreaRecruiting
Chungnam National University Sejong Hospital
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SejongSouth KoreaRecruiting
Seoul university Bundang hospital
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SeongnamSouth KoreaRecruiting
Korea University Guro Hospital
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SeoulSouth KoreaTerminated
Seoul National University Boramae Medical Center
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SeoulSouth KoreaRecruiting
Kangdong KyungHee University hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
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SeoulSouth KoreaWithdrawn
The Catholic Univ. of Korea Seoul St. Mary's Hospital
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SeoulSouth KoreaActive, not recruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Ewha Womans University Mokdong Hospital
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SeoulSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Severance hospital
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SeoulSouth KoreaWithdrawn
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Ajou University Hospital
Coordinator of this site? Confirm its status
SuwonSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.