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

RecruitingPhase 4Ages 18 Years - anyAllKee-joon Choi
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ0.1mV) 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 โ‰ฅ3) * Life expectancy \<2 years * Psychiatric illnesses that may be aggravated by device implantation or that may preclude systematic follow-up
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What it tests

  • Implantable Cardioverter Defibrillator
  • Optimal Medical Therapy
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Where

26 sites
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, South Korea
Busan National University Yangsan Hospital
Busan, South Korea
Busan University Hospital
Busan, South Korea
Dong-A Medical Center
Busan, South Korea
Soon Chun Hyang University Hospital Cheonan
Cheonan, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Gangneung Asan Hospital
Gangneung, South Korea

โ€ฆand 18 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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