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

Asan Medical Center0 个研究点目标入组 140 人开始时间: 待定最近更新: 2023年5月30日

适应症

试验速览

暂无简介。

•1Age 18 years or older
•2Patients experienced successfully resuscitated cardiac arrest due to documented ventricular fibrillation or sustained rapid ventricular tachycardia within 6 months of randomization
•3Normal on coronary angiogram as no evidence of =50% stenosis or ischemic lesion and diagnosed as variant angina which is defined by spontaneous coronary spasm with ST elevation (=0.1mV) or =90% of lumen loss in the coronary angiogram on ergonovine provocation coronary angiography
•4Patent or legal representative agrees to the trial protocol and follow-up surveillence and provides written informed consent on IRB/EC approved template

•1Significant (>50%) coronary artery stenosis on coronary angiography
•2Organic heart disease known to be associated with sudden cardiac arrest.
•- Heart failure with reduced ejection fraction (LV EF < 35%)
•- Presence of LV akinesia or aneurysm
•- Hypertrophic cardiomyopathy
•- Arrhythmogenic right ventricular dysplasia
•3CHF New York Heart Association functional class III or IV
•4prior history of atrial or ventricular arrhythmia requiring class I or III antiarrhythmic drugs (flecainide, propafenone, amiodarone, sotalol and dronedarone)
•5Primary cardiac electrical diseases (long QT syndrome, Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia)
•6Prior pacemaker or Implantable Cardioverter Defibrillator (ICD)
•72nd or 3rd degree AV block not related to coronary ischemia, requiring permanent pacemaker
•8Patients with poor neurologic outcome (defined as cerebral performance category scale =3)
•9Significant abnormalities on physical examination, blood test, ecg on screening visit and at the discretion of investigator
•10Likely to not be available to adhere to protocol procedure
•11Pregnant, breast feeding or in childbearing age
•12Life expectancy =2years

发起方