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:

  1. Age ≥18 years.
  2. Naïve to implantation of any pacemaker or defibrillator
  3. 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.
  4. Symptomatic heart failure with New York Heart Association (NYHA) class II or III.
  5. On OMT for at least 3 months prior to enrolment.
  6. LVEF ≤ 35% (at transthoracic echocardiography or cardiac magnetic resonance imaging [MRI] at least 3 months after MI).
  7. 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:

  1. Class I or IIa indication for implantation of an ICD for secondary prevention of SCD and ventricular tachycardia.

  2. Ventricular tachycardia induced in an electrophysiologic study.

  3. Unexplained syncope when ventricular arrhythmia is suspected as the cause of syncope.

  4. Class I or IIa indication for Cardiac Resynchronization Therapy (CRT)

  5. Foreseable violation of instruction for use (IFU) of the ICD device selected for implantation (valid for control group patients, only).

  6. Acute coronary syndrome or coronary angioplasty or coronary artery bypass grafting performed within 6 weeks prior to enrolment.

  7. Cardiac valve surgery or percutaneous cardiac valvular intervention performed within 6 weeks prior to enrolment.

  8. 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.

  9. Any known disease that limits life expectancy to less than 1 year.

  10. Participation in another randomised clinical trial if study-specific treatment is still active at enrolment into PROFID EHRA.

  11. 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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 22 (86 locations)

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