Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

Launched by CHARITE UNIVERSITY, BERLIN, GERMANY · Dec 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying whether patients who have survived a heart attack (myocardial infarction, or MI) and have weakened heart function can safely avoid getting an implantable cardioverter-defibrillator (ICD), which is a device that helps prevent sudden cardiac death. The trial is specifically looking at patients with a reduced heart pumping ability (left ventricular ejection fraction, or LVEF, of 35% or less) who are receiving optimal medical treatment for their heart condition. Researchers want to find out if these patients can do just as well with medication alone, without the added risks and costs of getting an ICD.

To be eligible for this trial, participants need to be at least 18 years old and must have had a heart attack at least 3 months prior to joining. They should be experiencing symptoms of heart failure and have been on optimal medical treatment for at least 3 months. Not everyone can participate, though; those who already need an ICD for other reasons or have certain heart conditions may not qualify. If you join the trial, you will be monitored closely to see how well you do with just the medication compared to those who receive both medication and the ICD. This study aims to improve care for patients like you by understanding the best treatment options available.

Gender

ALL

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.