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Prevention study for Sudden Cardiac Death
Official title Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation
ClinicalTrials.gov ID: NCT05665608
What this study is testing
What is Optimal Medical Therapy (OMT)?
Optimal Medical Therapy (OMT) is an investigational medicine, being studied as a potential treatment for sudden cardiac death.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 ventricular ejection fraction (LVEF) as a rough overall measure of impaired heart function after MI was shown to indicate a higher risk for SCD.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)...
- Symptomatic heart failure with New York Heart Association (NYHA) class II or III.
- On OMT for at least 3 months prior to enrolment.
You likely can't join if
- Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.
- Ventricular tachycardia induced in an electrophysiologic study.
- Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
- Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)
- Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).
- Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.
See the full eligibility 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
- Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.
- Ventricular tachycardia induced in an electrophysiologic study.
- Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.
- Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)
- Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).
- Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.
- Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.
- 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...
- Any known disease that limits life expectancy to less than 1 year.
- Participation in another assigned by chance clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Feldkirch, Austria
- Graz, Austria
- Innsbruck, Austria
- Klagenfurt, Austria
- Linz, Austria
- Salzburg, Austria
- Sankt Pölten, Austria
- Wels, Austria
- Wiener Neustadt, Austria
- Aalst, Belgium
- Bruges, Belgium
- Liège, Belgium
- Yvoir, Belgium
- Olomouc, Czechia
- Prague, Czechia
- Ústí nad Labem, Czechia
- Aarhus, Denmark
- Amiens, France
- Brest, France
- Créteil, France
+ 52 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Feldkirch, Austria; Graz, Austria; Innsbruck, Austria; Klagenfurt, Austria; Linz, Austria; Salzburg, Austria and 66 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.