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Shock therapy: can a heart device save lives in rare angina?

NCT ID NCT02845531

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Suwon, South Korea

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Busan National University Yangsan Hospital

    RECRUITING

    Busan, South Korea

  • Busan University Hospital

    ACTIVE_NOT_RECRUITING

    Busan, South Korea

  • Chonbuk National University Hospital

    RECRUITING

    Jeonju, South Korea

  • Chonnam National University Hospital

    RECRUITING

    Gwangju, South Korea

  • Chungnam National University Hospital

    RECRUITING

    Daejeon, South Korea

  • Chungnam National University Sejong Hospital

    RECRUITING

    Sejong, South Korea

  • Dong-A Medical Center

    RECRUITING

    Busan, South Korea

  • Ewha Womans University Mokdong Hospital

    RECRUITING

    Seoul, South Korea

  • Gachon University Gil Medical Center

    RECRUITING

    Incheon, South Korea

  • Gangneung Asan Hospital

    WITHDRAWN

    Gangneung, South Korea

  • Inje University Ilsan Paik Hospital

    RECRUITING

    Ilsan, South Korea

  • Kangdong KyungHee University hospital

    RECRUITING

    Seoul, South Korea

  • Keimyung University Dongsan Medical Center

    RECRUITING

    Daegu, South Korea

  • Korea University Anam Hospital

    RECRUITING

    Seoul, South Korea

  • Korea University Guro Hospital

    TERMINATED

    Seoul, South Korea

  • Seoul National University Boramae Medical Center

    RECRUITING

    Seoul, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Seoul university Bundang hospital

    RECRUITING

    Seongnam, South Korea

  • Severance Hospital

    WITHDRAWN

    Seoul, South Korea

  • Soon Chun Hyang University Hospital Bucheon

    RECRUITING

    Bucheon-si, South Korea

  • Soon Chun Hyang University Hospital Cheonan

    ACTIVE_NOT_RECRUITING

    Cheonan, South Korea

  • The Catholic Univ. of Korea, Seoul St. Mary's Hospital

    ACTIVE_NOT_RECRUITING

    Seoul, South Korea

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    WITHDRAWN

    Seoul, South Korea

  • Wonkwang University Hospital

    WITHDRAWN

    Iksan, South Korea

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