PRevention Of sudden cardiac death aFter myocardial Infarction by Defibrillator implantatio

Not Applicable

Recruiting

• Conditions: post-myocardial infarction patients with symptomatic heart failure and with reduced LVEF =35%; on OMT for this conditionSymptomatic heart failure with New York Heart Association (NYHA) class II or IIILVEF = 35%history of myocardial infarction either as ST segment elevation myocardial infarction (STEMI) or as non-ST segment elevation myocardial infarction (NSTEMI)

• Registration Number: DRKS00031770
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3595

Inclusion Criteria

I2. Naïve to implantation of any pacemaker or defibrillator.
I3. 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.
I4. Symptomatic heart failure with New York Heart Association (NYHA) class II or III.
I5. On OMT for at least 3 months prior to enrolment.
I6. LVEF =35% (at transthoracic echocardiography (TTE) or cMRI at least 3 months after MI and at least 3 months prior to enrolment).
I7. Signed informed consent.

Exclusion Criteria

E1. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.
E2. Ventricular tachycardia induced in an electrophysiologic study.
E3. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
E4. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT).
E5. Foreseeable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).
E6. Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.
E7. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.
E8. On the waiting list for heart transplantation.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time from randomisation to the occurrence of all-cause death.

Secondary Outcome Measures

Name	Time	Method
2. Time from randomisation to death from cardiovascular causes.<br>3. Time from randomisation to SCD.<br>4. Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation.<br>5. Average length of stay in hospital during the study period.<br>6. Quality of life (EQ-5D-5L) trajectories over time at baseline and 6-month intervals thereafter.<br><br>Primary and secondary outcome parameters based on clinical events will be adjudicated by an independent Endpoint Review Committee (ERC).