heart attack sudden cardiac death heart attack sudden cardiac death
Conditions
Interventions
No investigational medical product is defined to be used within PROFID EHRA but
only the therapeutic strategy (ICD versus no ICD) is a pre-defined study
treatment and allocated by random group (Proo
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: I1. Age >=18 years. 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
Exclusion criteria
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. E9. Any known disease that limits life expectancy to less than 1 year. E10. Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA. E11. Previous participation in PROFID.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| O1. Time from randomisation to the occurrence of all-cause death. | — |
Secondary
| Measure | Time frame |
|---|---|
| O2. Time from randomisation to death from cardiovascular causes. O3. Time from randomisation to SCD. O4. Time from randomisation to first hospital readmissions for cardiovascular causes after date of randomisation. O5. Average length of stay in hospital during the study period. O6. Quality of life (EQ-5D-5L) trajectories over time at baseline and 12-month intervals thereafter. | — |
Countries
Austria, Belgium, Czech Republic, Denmark, France, Germany, Hungary, Israel, Netherlands, Poland, Portugal, Spain, United Kingdom
Contacts
Public ContactND Dagres
Charié Universitätsmedizin Berlin
Outcome results
None listed