← Back to Clinical Trials
Recruiting Phase 4 NCT02845531

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

Trial Parameters

Condition Angina Pectoris, Variant
Sponsor Kee-joon Choi
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 140
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2016-11-29
Completion 2030-12
Interventions
Implantable Cardioverter DefibrillatorOptimal Medical Therapy

Brief Summary

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.

Eligibility Criteria

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 dronedar

Related Trials