Status:
RECRUITING
Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Sudden Cardiac Death
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ven...
Eligibility Criteria
Inclusion Criteria:
- 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 myocardial infarction (NSTEMI) at least 3 months prior to enrolment.
- Symptomatic heart failure with New York Heart Association (NYHA) class II or III.
- On OMT for at least 3 months prior to enrolment.
- LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging [MRI] at least 3 months after MI).
- 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:
-
Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.
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Ventricular tachycardia induced in an electrophysiologic study.
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Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
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Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)
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Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).
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Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.
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Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.
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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.
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Any known disease that limits life expectancy to less than 1 year.
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Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.
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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.
Key Trial Info
Start Date :
November 16 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
3595 Patients enrolled
Trial Details
Trial ID
NCT05665608
Start Date
November 16 2023
End Date
November 30 2027
Last Update
April 1 2026
Active Locations (86)
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1
Landeskrankenhaus Feldkirch
Feldkirch, Austria, 6800
2
LKH Universitätsklinikum Graz
Graz, Austria, 8036
3
Tirol Kliniken - Universitätsklinik Innsbruck
Innsbruck, Austria, 6020
4
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria, 9020