Implantable Cardioverter Defibrillator Versus Optimal Medical Therapy In Patients With Var
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.
| Condition(s) | Angina Pectoris, Variant, Sudden Cardiac Death |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 H |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Kee-joon Choi |
| Locations | Bucheon-si, South Korea; Busan, South Korea; Busan, South Korea; Busan, South Korea; Cheonan, South Korea; Daegu, South Korea (+19 more sites) |
| Start date | 2016-11-29 |
| NCT ID | NCT02845531 |
| Official listing | https://clinicaltrials.gov/study/NCT02845531 |