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

Sudden Cardiac Death Clinical Trial

— VARIANT ICD  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02845531
• Other study ID #: AMCCV2016-15
• Status: Recruiting
• Phase: Phase 4
• Start date: November 29, 2016
• Est. completion date: June 2030

Study information

• Verified date: February 2024
• Source: Asan Medical Center
• Contact: Kee-joon Choi, MD
• Email: kjchoi[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

All participants will be monitored over a span of five years and the time point of the year of last subject last visit. The term "year of last subject last visit" refers to the time point of the last visit for all participants. At this specific time point, event occurrence check will be conducted to determine the occurrence of endpoint events among all participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: June 2030
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• 2nd 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

Related Conditions & MeSH terms

• Angina Pectoris
• Angina Pectoris, Variant
• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Intervention

Device:
• Implantable Cardioverter Defibrillator
Implantable Cardioverter Defibrillator and Optimal Medical Therapy

Drug:
• Optimal Medical Therapy

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Busan National University Yangsan Hospital	Busan
Korea, Republic of	Busan University Hospital	Busan
Korea, Republic of	Dong-A Medical Center	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Wonkwang University Hospital	Iksan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong
Korea, Republic of	Seoul university Bundang hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Kangdong KyungHee University hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic Univ. of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (2)

Lead Sponsor	Collaborator
Kee-joon Choi	CardioVascular Research Foundation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death from any cause		5 years
Secondary	Event rate of Cardiac death		5 years
Secondary	Event rate of Death from arrhythmia		5 years
Secondary	Event rate of Cardiac arrest		5 years
Secondary	Event rate of Recurrence of ventricular tachyarrhythmia		5 years
Secondary	Event rate of Hospitalization	Hospitalization due to unstable angina, acute myocardial infarction, heart failure, cardiac arrhythmia	5 years
Secondary	Event rate of Appropriate ICD therapies	Appropriate ICD therapies defined as device-administered antitachycardia or defibrillation treatment for ventricular tachyarrhythmia that had not terminated spontaneously	5 years
Secondary	Event rate of Inappropriate ICD therapies		5 years
Secondary	Event rate of Major device-related complications		5 years
Secondary	Event rate of Stroke		5 years