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

  • STATUS
    Recruiting
  • End date
    Jun 24, 2023
  • participants needed
    140
  • sponsor
    Kee-joon Choi
Updated on 24 January 2021

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.

Details
Condition Sudden Cardiac Death, Prinzmetal Angina
Treatment Implantable Cardioverter Defibrillator, Optimal medical therapy
Clinical Study IdentifierNCT02845531
SponsorKee-joon Choi
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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 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
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