Shock therapy: can a heart device save lives in rare angina?
NCT ID NCT02845531
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding an implantable cardioverter defibrillator (ICD) to standard medication helps people with variant angina who have survived a sudden cardiac arrest. About 140 adults will be randomly assigned to get either an ICD plus medication or medication alone. The main goal is to see which group has fewer deaths from any cause.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Implantable Cardioverter Defibrillator (ICD) and optimal medical therapy
- What this could lead to
- If the ICD proves better, it could become a standard addition to medication for preventing death in variant angina patients who have survived a cardiac arrest.
- What could go wrong
- This is a Phase 4 trial with 140 participants, so results may not apply to all patients. The ICD itself carries risks like infection or inappropriate shocks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Nov 2016
- Expected to finish
-
Jun 2031
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Angina pectoris, variant are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
18 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Ajou University Hospital
RECRUITINGSuwon, South Korea
-
Asan Medical Center
RECRUITINGSeoul, South Korea
-
Busan National University Yangsan Hospital
RECRUITINGBusan, South Korea
-
Busan University Hospital
ACTIVE_NOT_RECRUITINGBusan, South Korea
-
Chonbuk National University Hospital
RECRUITINGJeonju, South Korea
-
Chonnam National University Hospital
RECRUITINGGwangju, South Korea
-
Chungnam National University Hospital
RECRUITINGDaejeon, South Korea
-
Chungnam National University Sejong Hospital
RECRUITINGSejong, South Korea
-
Dong-A Medical Center
RECRUITINGBusan, South Korea
-
Ewha Womans University Mokdong Hospital
RECRUITINGSeoul, South Korea
-
Gachon University Gil Medical Center
RECRUITINGIncheon, South Korea
-
Gangneung Asan Hospital
WITHDRAWNGangneung, South Korea
-
Inje University Ilsan Paik Hospital
RECRUITINGIlsan, South Korea
-
Kangdong KyungHee University hospital
RECRUITINGSeoul, South Korea
-
Keimyung University Dongsan Medical Center
RECRUITINGDaegu, South Korea
-
Korea University Anam Hospital
RECRUITINGSeoul, South Korea
-
Korea University Guro Hospital
TERMINATEDSeoul, South Korea
-
Seoul National University Boramae Medical Center
RECRUITINGSeoul, South Korea
-
Seoul National University Hospital
RECRUITINGSeoul, South Korea
-
Seoul university Bundang hospital
RECRUITINGSeongnam, South Korea
-
Severance Hospital
WITHDRAWNSeoul, South Korea
-
Soon Chun Hyang University Hospital Bucheon
RECRUITINGBucheon-si, South Korea
-
Soon Chun Hyang University Hospital Cheonan
ACTIVE_NOT_RECRUITINGCheonan, South Korea
-
The Catholic Univ. of Korea, Seoul St. Mary's Hospital
ACTIVE_NOT_RECRUITINGSeoul, South Korea
-
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
WITHDRAWNSeoul, South Korea
-
Wonkwang University Hospital
WITHDRAWNIksan, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can genes explain sudden cardiac death in young athletes?
- Can we predict sudden cardiac arrest in heart disease patients?
- Tiny heart monitor could uncover why dialysis patients die suddenly
- Heart disease detective: 1,000-Person study hunts for hidden genetic triggers of sudden cardiac death
- AI could prevent sudden cardiac death in young athletes
- Virtual heart twin could predict who needs a defibrillator