Tests whether a defibrillator device is needed after a heart attack

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had a heart attack at least 3 months ago and now have symptomatic heart failure with a weak heart pump (LVEF ≤ 35%) despite optimal medical treatment.

Age

18 years or older

Sex

All sexes

Disease stage

Heart attack (STEMI or NSTEMI) at least 3 months ago; heart failure with symptoms (NYHA class II or III); LVEF ≤ 35% measured by echocardiography or cardiac MRI at least 3 months after the heart attack.

Earlier treatment

Must have been on optimal medical therapy for at least 3 months. Must never have had a pacemaker or defibrillator implanted.

Biomarker or test result

LVEF ≤ 35%

Main reasons for not taking part

• A clear indication for an ICD for secondary prevention, or ventricular tachycardia induced in an electrophysiologic study
• A clear indication for cardiac resynchronization therapy (CRT)
• Acute coronary syndrome, angioplasty, bypass surgery or heart valve surgery or intervention within 6 weeks before enrolment
• On the waiting list for a heart transplant
• Any known disease that limits life expectancy to less than 1 year

The registry criteria, word for word

What the trial wants to find out

Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation. A severely reduced left ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD. Based on this observation, two landmark randomised trials, MADIT II and SCD-HeFT, were conducted between end of the 1990s and early 2000s. These trials compared the survival of patients with severely reduced LVEF who received an implantable cardioverter-defibrillator with the survival of patients being on medical therapy alone. They reported a significantly better survival of patients in the defibrillator arm and led to international guideline recommendations for routine implantation of defibrillators in survivors of MI with severely impaired LVEF as a means for primary prevention of SCD. Since then, the management of these patients has changed dramatically with the advent of a series of novel drug classes that reduce not only mortality but specifically SCD leading to a substantial decrease of the sudden death rates as well as of the rates of appropriate defibrillator therapies implanted for primary prevention of SCD. At the same time, the complication rates associated with the defibrilllator therapy remain significant without obvious decrease. Thus, the risk-benefit of routine defibrillator implantation for primary prevention of SCD in patients with severely reduced LVEF has substantially changed since the conduction of the landmark trials that established this therapy. Due to the inherent risks and considerable costs of the defibrillator, a novel randomised adequately powered assessment of the potential benefit or harm of the defibrillator in survivors of MI with reduced LVEF under contemporary optimal medical treatment (OMT) appears imperative.

The 2 groups in the trial

• Optimal Medical Therapy with ICD device therapyExisting treatment, for comparison

  Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will receive an ICD device

  Treatment: Implantable cardioverter-defibrillator (ICD) and Optimal Medical Therapy (OMT)

• Optimal Medical Therapy without ICD device therapyTreatment being tested

  Patients will be treated according to Optimal Medical Therapy defined by ESC Guidelines for treatment of patients with heart failure / chronic coronary syndromes and will not receive an ICD device

  Treatment: Optimal Medical Therapy (OMT)