Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

Plain English Summary

Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation is a Not Applicable clinical trial sponsored by Charite University, Berlin, Germany studying Sudden Cardiac Death, Myocardial Infarction. This trial tests if an implantable cardioverter-defibrillator (ICD) can help prevent sudden cardiac death in people who have had a heart attack. It is for patients who have had a heart attack at least 3 months ago, have symptoms of heart failure, and have a weakened heart function. Participants will be randomly assigned to either receive an ICD or continue with optimal medical therapy. Alternatives include optimal medical therapy alone, or potentially a subcutaneous defibrillator in specific cases. The trial aims to enroll 3595 participants.

Official Summary

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 Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older and have not had a pacemaker or defibrillator before. You must have had a heart attack (STEMI or NSTEMI) at least 3 months ago and be experiencing heart failure symptoms (NYHA class II or III). Your heart's pumping function (LVEF) must be 35% or less, and you must have been on optimal medical treatment for at least 3 months. You cannot join if you already have a strong indication for an ICD for secondary prevention, have had recent heart surgery, are awaiting a heart transplant, or have a life expectancy of less than 1 year. This trial is studying Sudden Cardiac Death, Myocardial Infarction, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how long patients live without dying from any cause, helping to understand if the defibrillator improves overall survival. The specific primary outcome measures are: Time from randomisation to the occurrence of all-cause death. (event-driven, expected about 15 months after last patient in). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial is important because new medications have changed how patients with weakened hearts after a heart attack are treated, and it's crucial to re-evaluate if defibrillators are still the best op This research targets Sudden Cardiac Death, Myocardial Infarction, where improved treatment options are needed.

Investor Insight

This trial addresses a significant market for cardiac devices and therapies, aiming to clarify the role of ICDs in primary prevention amidst evolving medical treatments and potential cost-effectivenes The large enrollment target of 3595 participants suggests significant investment in this program.

Is This Trial Right for Me?

Ask your doctor if an ICD is right for you and what the risks and benefits are. Understand that you will be randomly assigned to a treatment group, and participation involves regular check-ups and potential device monitoring. Be aware that this trial involves an invasive procedure to implant the defibrillator. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 3,595 participants

Interventions

• DEVICE: Implantable cardioverter-defibrillator (ICD) — A transvenous ICD consists of an electronic medical device and electrode leads. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing). The subcutaneous defibrillator is an established and valid alternative to the transvenous ICD for the prevention of SCD, but in patients without an indication for bradycardia support, cardiac resynchronisation or antitachycardia pacing. The extrav
• DRUG: Optimal Medical Therapy (OMT) — Patients will be treated according to Optimal Medical Therapy defined by the following guidelines: 1. 2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes 2. 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure

Primary Outcomes

• Time from randomisation to the occurrence of all-cause death. (event-driven, expected about 15 months after last patient in)

Secondary Outcomes

• Time from randomisation to death from cardiovascular causes (Randomization to end of study (event-driven, expected about 15 months after last patient in)
• Time from randomisation to sudden cardiac death (Randomization to end of study (event-driven, expected about 15 months after last patient in)
• Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation (Randomization to end of study (event-driven, expected about 15 months after last patient in)
• Average length of stay in hospital during the study period (Randomization to end of study (event-driven, expected about 15 months after last patient in)
• Quality of life (EQ-5D-5L) trajectories over time (At baseline and 12-month intervals thereafter)

Full Eligibility Criteria

Inclusion Criteria:

1. Age ≥18 years.
2. Naïve to implantation of any pacemaker or defibrillator
3. Documented history of MI either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI) at least 3 months prior to enrolment.
4. Symptomatic heart failure with New York Heart Association (NYHA) class II or III.
5. On OMT for at least 3 months prior to enrolment.
6. LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging \[MRI\] at least 3 months after MI).
7. Signed informed consent.

Inclusion criterion I3 defines myocardial infarction according to the 2018 ESC/ACC/AHA/WHF Fourth Universal Definition of myocardial infarction

Exclusion Criteria:

1. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.
2. Ventricular tachycardia induced in an electrophysiologic study.
3. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
4. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)
5. Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).
6. Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.
7. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.
8. On the waiting list for heart transplantation.

   Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachy-cardia has to be assessed according to the 2022 ESC Guidelines for the management of patients with ven-tricular arrhythmias and the prevention of SCD.
9. Any known disease that limits life expectancy to less than 1 year.
10. Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.
11. Previous participation in PROFID EHRA.

Parallel participation in sub-studies connected to this trial is permitted as well as in purely observational studies without any pre-defined intervention.

Trial Locations

• Landeskrankenhaus Feldkirch, Feldkirch, Austria
• LKH Universitätsklinikum Graz, Graz, Austria
• Tirol Kliniken - Universitätsklinik Innsbruck, Innsbruck, Austria
• Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria
• Ordensklinikum Linz GmbH Elisabethinen, Linz, Austria
• Landeskrankenhaus Salzburg - Universitätsklinikum der PMU, Salzburg, Austria
• Universitätsklinikum St. Pölten, Sankt Pölten, Austria
• Klinikum Wels-Grieskirchen GmbH, Wels, Austria
• Universitätsklinikum Wiener Neustadt, Wiener Neustadt, Austria
• OLV Ziekenhuis Campus Aalst, Aalst, Belgium
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Sudden Cardiac Death
• Myocardial Infarction
• Heart Failure
• Ventricular Tachycardia
• Ventricular Fibrillation
• Arrhythmia
• Coronary Artery Disease
• Cardiovascular Disease
• Ischemic Heart Disease
• Cardiomyopathy

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