DRKS00031770
Recruiting
未知
PRevention Of sudden cardiac death aFter myocardial Infarction by Defibrillator implantation - PROFID EHRA
Conditionspost-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)
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- post-myocardial infarction patients with symptomatic heart failure and with reduced LVEF =35%
- Sponsor
- Charité - Universitätsmedizin Berlin
- Enrollment
- 3595
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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