RecruitingPhase 4NCT02845531
Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Variant Angina Manifesting as Aborted Sudden Cardiac Death
Sponsor
Kee-joon Choi
Enrollment
140 participants
Start Date
Nov 29, 2016
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria3
- 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 Criteria15
- 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
- nd 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
Interventions
DEVICEImplantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator and Optimal Medical Therapy
DRUGOptimal Medical Therapy
Locations(25)
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NCT02845531
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