At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Implantable cardioverter-defibrillator (ICD) (device), Optimal Medical Therapy (OMT) (drug)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Implantable cardioverter-defibrillator (ICD) — device: A transvenous ICD consists of an electronic medical device and electrode leads. · Optimal Medical Therapy (OMT) — drug: Patients will be treated according to Optimal Medical Therapy defined by the following guidelines: 1.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by Charite University in Berlin, Germany, looks at preventing sudden cardiac death in people who have had a heart attack (myocardial infarction). It involves implantable cardioverter defibrillators (ICDs), which are devices placed in the body to correct dangerous heart rhythms.
Who can take part
- Adults aged 18 or over
- Never had a pacemaker or defibrillator implanted before
- Had a heart attack (either STEMI or NSTEMI type) at least 3 months before joining
- Have symptomatic heart failure, class II or III on the New York Heart Association (NYHA) scale
- On best medical treatment (OMT) for at least 3 months before joining
- Heart pumping strength (LVEF) of 35% or less, measured by heart ultrasound or heart MRI scan at least 3 months after the heart attack
- Able to give signed informed consent
Who may not be able to
- Already advised to have a defibrillator (ICD) to prevent sudden cardiac death or ventricular tachycardia (a fast abnormal heart rhythm)
- Ventricular tachycardia found during a heart electrical test
- Unexplained fainting thought to be caused by an abnormal heart rhythm
- Advised to have cardiac resynchronization therapy (CRT), a special pacemaker-type device
- Reasons the chosen ICD device instructions could not be followed (for control group patients only)
- A heart attack, angioplasty or bypass surgery within the 6 weeks before joining
- Heart valve surgery or valve procedure within the 6 weeks before joining
- On the waiting list for a heart transplant
- A known illness likely to limit life expectancy to under 1 year
- Taking part in another trial with an active treatment, or previously took part in this trial
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 3,595
- Started
- 2023-11-16
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for sudden cardiac death
- • NA - 3,595 participants
- • Patients who have survived a myocardial infarction (MI) are at increased risk for sudden cardiac death (SCD) caused by ventricular tachycardia and ventricular fibrillation
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with sudden cardiac death
Where?
- • Halifax - Calderdale Royal Hospital
- • Leeds - The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
- • Margate - Queen Elizabeth The Queen Mother Hospital Margate
- • Nuneaton - George Eliot Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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. OBJECTIVE: To demonstrate that in post-MI patients with symptomatic heart failure who receive OMT for this condition, and with reduced LVEF ≤ 35%, OMT without ICD implantation (index group) is not inferior to OMT with ICD implantation (control group) with respect to all-cause mortality.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Age ≥18 years.
- ✓Naïve to implantation of any pacemaker or defibrillator
- ✓Documented history of MI either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation...
- ✓causing symptoms heart failure with New York Heart Association (NYHA) class II or III.
- ✓On OMT for at least 3 months prior to enrolment.
Who cannot take part
- ✗Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.
- ✗Ventricular tachycardia induced in an electrophysiologic study.
- ✗Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
- ✗Class I or IIa indication for heart Resynchronization Therapy (CRT)
- ✗Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control...
See the full criteria
Where Is This Study? (6 UK sites)
Calderdale Royal Hospital
Halifax HX3 0PW, United Kingdom
The Leeds Teaching Hospitals NHS Trust - St James's University Hospital
Leeds LS9 7TF, United Kingdom
Queen Elizabeth The Queen Mother Hospital Margate
Margate CT9 4AN, United Kingdom
George Eliot Hospital
Nuneaton CV10 7DJ, United Kingdom
Salisbury District Hospital
Salisbury SP2 8BJ, United Kingdom
University Hospital of North Tees
Stockton-on-Tees TS19 8PE, United Kingdom
Research and Development
nth-tr.ntandh.researchdevelopment@nhs.net01642 624090How to Get in Touch
Gerhard Hindricks, Prof
Sponsor contactCONTACT
Nikolaos Dagres, MD
Sponsor contactCONTACT